Valve Delivery Tool

ABSTRACT

A system includes a medical device for implanting in a valve of a subject, the implantable medical device having a self-expanding frame; and a holder configured to retain the frame of the implantable medical device in a constricted configuration and to control expansion of the frame. The holder has a controllably constrictable and expandable loop, wherein the loop is disposed about at least a portion of the self-expanding frame such that constriction or expansion of the first loop controls constriction or expansion of the frame.

RELATED APPLICATIONS

The application claims the benefit of U.S. Provisional PatentApplication No. 61/819,488, filed on May 3, 2013; U.S. ProvisionalPatent Application No. 61/819,492, filed on May 3, 2013; U.S.Provisional Patent Application No. 61/819,490, filed on May 3, 2013; andU.S. Provisional Patent Application No. 61/930,905, filed on Jan. 23,2014, each of which is hereby incorporated herein in its entirety to theextent that it does not conflict with the disclosure presented herein.

FIELD

The present disclosure relates to, among other things, tools fordelivering implantable medical devices having self-expanding frames,such as prosthetic heart valves.

BACKGROUND

A number of self-expanding implantable medical devices, such asprosthetic heart valves that have self-expanding frames, are known. Anumber of delivery systems and tools to aid in implanting such medicaldevices are known. However, improved delivery tools or systems orassociated devices that can aid in implanting such devices are desired.

SUMMARY OF SOME EMBODIMENTS

In some embodiments, minimally invasive sutureless valve delivery toolsare described herein.

In some embodiments, the delivery tools comprise a side mounted holder.

Some embodiments of the delivery tools described herein are easy to use.

In various embodiments, tool described herein allow rapid and simpleconnection with the valve.

In some embodiments, tools described herein allow a surgeon to visualizethe seating of the valve at a patient's annulus.

Various embodiments of the tools described herein allow a surgeon tohave solid control over valve positioning while expanding the valve at adesirable rate.

In some embodiments, the tools are configured to allow improvedvisualization by flaring the skirt during deployment and by using a lowprofile or side mounted interface between the handle and the valve.

In various embodiments, the tools described herein allow for easyrepositioning of the valve. For example, a handle of the tool may bereadily reconnected to the valve if the surgeon is not satisfied withvalve placement.

Advantages of one or more of the various embodiments presented hereinover prior devices for implanting in a valve sinus of a patient, such asprosthetic heart valves, and associated methods will be readily apparentto those of skill in the art based on the following detailed descriptionwhen read in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-B are schematic drawings of side views of an embodiment of aholder and self-expanding implantable medical device, where the deviceis in a constricted configuration (1A) and an expanded configuration(1B).

FIGS. 2A-B are schematic drawings of top views of an embodiment of aholder and self-expanding implantable medical device, where the deviceis in a constricted configuration (2A) and an expanded configuration(2B).

FIG. 3 is a schematic drawing of a side view of an embodiment of aholder and self-expanding implantable medical device.

FIGS. 4A-B are schematic drawings of a side view (4A) and a top view(4B) of an embodiment of a holder and self-expanding implantable medicaldevice.

FIG. 5 is a schematic drawing of a side view of an embodiment of aholder and self-expanding implantable medical device.

FIG. 6 is a schematic drawing of a top view of an embodiment of anadaptor of a holder.

FIGS. 7-9 are schematic drawings of side views of embodiments ofdelivery systems, or components thereof,

FIG. 10A is a schematic drawing of an exemplary valve in an openposition during peak flow.

FIG. 10B is a schematic drawing of the valve of FIG. 10A in a closedposition to prevent backflow of the fluid across the valve.

FIG. 11A is a schematic drawing of a top view illustrating the anatomyof a typical aortic valve.

FIG. 11B is a schematic drawing of a cross-sectional view of the aorticvalve of FIG. 11A.

FIG. 11C is a schematic perspective view of the aortic valve of FIG. 11Ashowing the inflow end, outflow end, and commissural posts in phantomlines.

FIG. 12 is a schematic representation of the geometry and relativedimensions of the valve sinus region.

FIG. 13 is a schematic perspective view of a valve replacement system,which includes a replacement valve, a valve support structure (or“frame”), and a valve cuff.

FIG. 14 is a schematic perspective view of the replacement valve of FIG.13.

FIG. 15 is a schematic side view of the valve support structure of FIG.13 disposed inside a vessel.

FIG. 16 is a schematic side view of the replacement valve system of FIG.13.

FIG. 17 is a schematic view of the replacement valve system of FIGS. 13and 16 positioned within an aorta.

FIG. 18A is a schematic drawing of an embodiment of a support frame cutalong line A-A and laid flat.

FIG. 18B is a schematic drawing of a cross-sectional view illustratingthe concave landing zone of the frame of FIG. 18A.

FIG. 19 is a schematic drawing of an embodiment of a valve replacementsystem positioned in an aorta.

FIGS. 20A-B are schematic drawings of side views of an embodiment of aholder and prosthetic valve, where the prosthetic valve is in anexpanded configuration (20A) and a constricted configuration (20B).

FIGS. 21A-D are schematic side views showing a some steps of anembodiment of a procedure for implanting an embodiment of a prostheticvalve with an embodiment of a holder in a valve sinus of a patient.

FIGS. 22A-B are schematic top views of embodiments of suture styles forlooping one or more cords around at least a portion of a prostheticvalve.

FIG. 23 is a schematic bottom view of an embodiment of a holderpositioned relative to an embodiment of a prosthetic valve.

FIG. 24 is a schematic side view drawing illustrating an embodiment ofan extension of a holder.

FIG. 25 is a schematic sectional view of an embodiment of a shaft of adelivery system and an embodiment of an adaptor of a holder.

FIG. 26 is a schematic perspective view of an embodiment of a deliverysystem.

FIG. 27 is a schematic sectional view of an embodiment of a handle of adelivery system illustrating some components of an embodiment of atensioning apparatus.

FIG. 28 is a schematic drawing of a perspective view of some componentsof an embodiment of a cord and an embodiment of a tensioning apparatus.

FIG. 29 is a schematic partial cut away view of an embodiment of ahandle of a delivery system illustrating an embodiment of a tensioningapparatus.

FIG. 30 is a schematic sectional view of an embodiment of a handle of adelivery system illustrating an embodiment of a tensioning apparatus.

FIGS. 31-32 are schematic drawings of perspective views of embodimentsof delivery systems.

FIG. 33 is a schematic side view of an embodiment of a holder and anembodiment of a prosthetic valve.

FIG. 34A-B are schematic diagrams of a side view (34A) and a sectionalview (34B) of an embodiment of a holder.

FIG. 35 is a schematic drawing of an embodiment of a holder having crimplimiting elements and an associated prosthetic valve.

FIGS. 36A-B are schematic drawings of an embodiment of a holder havingcrimp limiting elements and an associated prosthetic valve.

FIG. 37 is a schematic drawing of an embodiment of a holder and anembodiment of a prosthetic valve in a mock-up of a valve sinus.

FIG. 38 is a schematic drawing of embodiments of cords having capturefeatures.

FIG. 39A is a schematic bottom view of an embodiment of a handle of adelivery system.

FIG. 39B is schematic drawing of a bottom of an embodiment of a handleof a delivery system.

FIGS. 40A-C are schematic perspective views of an embodiment of a handleand holder of a delivery system.

FIG. 41 is a schematic perspective view of a portion of an embodiment ofa shaft of a delivery system.

FIG. 42 is a schematic side view of an embodiment of a handle of adelivery system.

FIG. 43 is a schematic perspective view of an embodiment of a crimpingguide and an embodiment of a prosthetic valve.

FIGS. 44A-B are schematic side views of embodiment of a crimping guide,an embodiment of a prosthetic valve, and an embodiment of a crimpingfunnel

FIG. 45 is a schematic side view of embodiment of a crimping guide, anembodiment of a prosthetic valve, and an embodiment of a crimping funnel

FIG. 46 is a perspective view of an embodiment of a crimping funnel.

FIGS. 47A-47J, 48A-C, and 49-52 are schematic drawings of embodiments ofsizers. FIGS. 47A-E are top views of the sizers shown in the perspectiveviews of FIGS. 47F-J, respectively.

FIGS. 53-73 and 74A-B are schematic drawings illustrating someembodiments of prosthesis delivery systems.

The schematic drawings in are not necessarily to scale. Like numbersused in the figures refer to like components, steps and the like.However, it will be understood that the use of a number to refer to acomponent in a given figure is not intended to limit the component inanother figure labeled with the same number. In addition, the use ofdifferent numbers to refer to components is not intended to indicatethat the different numbered components cannot be the same or similar.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings that form a part hereof, and in which are shown byway of illustration several specific embodiments of devices, systems andmethods. It is to be understood that other embodiments are contemplatedand may be made without departing from the scope or spirit of thepresent disclosure. The following detailed description, therefore, isnot to be taken in a limiting sense.

Described herein, among other things, are devices, systems and methodsfor implanting medical devices having a self-expanding frame in apatient. In some embodiments, the medical devices are configured to beimplanted in a valve sinus of a patient. In some embodiments, themedical devices are prosthetic heart valves. In some embodiments, themedical devices are surgical prosthetic heart valves.

Some of the devices and systems described herein are holders forretaining self-expanding medical devices in a constricted configurationand for controlling expansion of the medical device. Delivery tools thatcan work cooperatively with such holders and that can aid in positioningthe self-expanding medical device or controlling expansion of the deviceare also described.

Methods for implanting devices using such tools and systems are alsodescribed, as well as additional tools or devices, such as sizers orcrimpers, to facilitate the implant process are also described.

Initially a conceptual overview of holders for retaining aself-expanding medical device in a constricted configuration and forcontrolling expansion of the device are described herein. Then,anatomical features of a valve of a subject and examples of prostheticheart valves configured to be implanted in a native valve of a subjectare described. Some embodiments of holders and delivery tools useful forimplanting heart valves in a native valve are then described. Adescription of accessory devices that can aid in the implantation ofprosthetic heart valves is then provided, followed by a summary of someselected embodiments of holders, systems including holders, andassociated implant methods is provided.

FIGS. 1-9 illustrate conceptual overviews of generic systems and devicesfor delivering a self-expanding medical device to a target location of apatient. FIGS. 10-19 illustrate anatomical features of a valve andexamples of prosthetic heart valves. FIGS. 20-42 illustrate some morespecific embodiments of systems and devices for implantingself-expanding prosthetic heart valves in a valve of a patient. FIGS.43-52 illustrate sizers and other accessory devices or tools that can behelpful in implanting a prosthetic heart valve. FIGS. 53-74 illustrateadditional embodiments of systems and devices for implantingself-expanding prostheses.

I. Overview of Generic Retaining or Delivering Systems and Devices

Referring to FIGS. 1-2, a system 500 that includes a holder 100 and amedical device 20 is shown. The medical device 20 has a self-expandingframe 24. The medical device 20 may be configured for implantation in avalve of a subject. In embodiments, the medical device 20 is aprosthetic heart valve, such as a sutureless surgical heart valve. Theholder 100 is configured to retain the frame 24 of the implantablemedical device in a constricted configuration and to control expansionof the frame. In FIGS. 1A (side view) and 2A (top view), the frame 24 isin a constricted configuration, and in FIGS. 1B (side view) and 2B (topview) the frame 24 is in an expanded configuration.

The holder 200 includes a controllably constrictable and expandable loop120. As used herein, “constrictable and expandable loop” means that thesize of an opening defined by the loop may be made smaller (constricted)or larger (expanded). The loop 120 is disposed about at least a portionof the self-expanding frame 24 such that constriction or expansion ofthe loop controls constriction or expansion of the frame. For purposesof the present disclosure “control of constriction or expansion of theframe” includes control of constriction or expansion of at least aportion of the frame.

The extent to which the frame may be constricted by the holder or asystem including the holder can be limited, because some frames may bedamaged if crimped to a diameter that is too small. Any suitable crimplimiting mechanism may be used. For example, a crimp limiter that limitsthe extent to which a loop may be constricted may be employed. By way offurther example, a crimp limited that limits the extent that a frame canbe constricted by be employed.

Some examples of crimp limiters are described below in more detail withregard to more specific embodiments.

In some embodiments (e.g., as depicted in FIGS. 1-2), the loop 120 isformed from a portion of a cord 125. A portion of the cord 125 extendsthrough a conduit 115 in extension member 110 of the holder such that anend 127 of the cord 125 extends beyond the extension member 110.Maintenance of tension on the cord 125 retains the loop 120 in arelatively constricted state (e.g., FIGS. 1A and 2A). Release of sometension on the cord 125 allows the loop 120 to expand as the frame 24 ofthe implantable medical device 20 self-expands (e.g., FIGS. 1B and 2B).

Referring now to FIG. 3, a side view of an embodiment of a system 500including a holder 100 and an implantable medical device 20 having aself-expandable frame 24 is shown. The embodiment shown in FIG. 3 issimilar to the embodiment shown in FIG. 1A, with like numbers referringto like components. In the embodiment depicted in FIG. 3, the holder 100include three loops 120, 130, 140 for controlling the expansion of theframe 24 of the device (e.g., as described above with regard to loop 120in FIGS. 1-2). The loops 120, 130, 140 may each be independentlyconstrictable and expandable or one or more of the loops may bedependently contstrictable or expandable (e.g., constriction of one loopresults in constriction of another loop). When used with devices where aconstriction of the frame in one location (e.g., around thecircumference in the middle of the frame) is not sufficient to preventexpansion of other portions of the frame (e.g., expansion of the top orbottom), more than one loop may be advantageously employed.

As shown in the embodiment depicted in FIG. 3, each loop 120, 130, 140is part of a cord 125, 135 145. The cords 125, 135 145 extend throughone or more conduits (not shown) of extension member 110. In someembodiments, all of the loops extend through the same conduit. In someembodiments, each cord extends through a separate conduit. In someembodiments, cords of loops that are dependently constrictable andexpandable extend through the same conduit.

It will be understood that a holder may include any suitable number ofloops, such as one (as depicted in FIGS. 1-2), two, three (e.g., asdepicted in FIG. 3), four, five or more. Any one or more of the loopsmay be independently or dependently constrictable and expandable. Insome embodiments, at least one loop is independently constrictable andexpandable relative to at least one other loop.

Referring now FIGS. 4A-B, a side view of an embodiment of systemincluding a holder 100 and device 20 having an expandable frame 24 isshown. The system depicted in FIGS. 4A and 4B is similar to theembodiment depicted in FIGS. 1A and 1B (with like numbers referring tolike components) except that extension 110 of holder is positioned atleast partially within a central opening of frame 24. Extension 110 maybe aligned with the longitudinal axis of the frame 24 as depicted.Alternatively, extension 110 may be offset from the longitudinal axis ofthe frame, may deviate from the axis by an angle, or the like. Forexample, in the embodiment depicted in FIG. 1A, the extension is offsetfrom, and parallel to, the longitudinal axis of the frame 24.

As shown in FIG. 4B, when a portion of the extension 110 from which theloop 120 or cord 125 that forms the loop is positioned within a centralopening of frame 24, a portion of the loop or cord extends from with thecentral opening of the frame to an edge of the frame so that the loop120 may restrain at least a portion of the frame 24.

A holder may have any suitable number of extensions, such as one, two,three, four, five, or more. In some embodiments, a holder has oneextension for each loop or cord. In some embodiments, a holder has moreextensions than loops or cords, with more than one cord running throughat least one extension. As discussed above, each extension may have anysuitable number of conduits. In some embodiments, an extension has asufficient number of conduits such that each cord that runs through theextension runs through a separate conduit. In some embodiments, morethan one cord extends through a given conduit of an extension.

Referring now to FIG. 5, an embodiment of a system 500 including aholder 100 and an implantable medical device 20 having a self-expandingframe 24 is shown. The depicted holder 100 has a first extension member110 and a second extension member 150. The extension members 110, 150are offset from, and substantially parallel to, the longitudinal axis ofthe frame 24 and are positioned external to the frame. Alternatively,the extension members may be positioned such that at least a portion iswithin a central opening of the frame or such that one is within theframe and another is external to the frame. As discussed above, anygiven extension member may be aligned with the longitudinal axis of theframe, offset from the longitudinal axis of the frame, parallel to thelongitudinal axis, extend at an angle from the longitudinal axis, or thelike.

In the embodiment depicted in FIG. 5, the first loop 120 is a part of afirst cord 125 that extends through a conduit of the first extensionmember 110 such that an end 127 of the cord 125 extends beyond the firstextension member 110. The second loop 130 is a part of a second cord 135that extends through a conduit of the second extension member 150 suchthat an end 137 of the cord 135 extends beyond the second extensionmember 110. The holder 110 includes an adaptor 160 through which aportion of the first 125 and second 135 cords extend. The adaptor 160may be a separate component from, or part of the same component as, oneor both of the extensions 120, 150. The adaptor 160 preferably retainsthe relative positions of the first 120 and second 150 extensionmembers. The adaptor 160 may also be configured to cooperatively matewith a shaft of a delivery device, which will be discussed below invarious embodiments.

Referring now to FIG. 6, a top view of the adaptor 160 depicted in FIG.5 is shown. The adaptor 160 has a first lumen 162 and a second lumen 164that extend through the adaptor 160. With reference to both FIGS. 5 and6, the first cord 125 extends through the first lumen 162 of the adaptor160 and the second cord 135 extends through the second lumen 164 of theadaptor.

An adaptor may have any number of lumens through which the cords mayextend. In some embodiments, an adaptor has a single lumen through whichall the cords extend. In some embodiments, an adaptor has a sufficientnumber of lumens for each cord to extend through a separate lumen. Insome embodiments, more than one cord extends through a lumen of anadaptor.

Referring now to FIG. 7, a holder 100 and shaft 210 are depicted. Theholder is similar to the holder depicted in FIG. 6, with similarnumerical identifiers referring to similar components. The holder 100 inFIG. 7 includes a first loop 120 as a part of a first cord 125 having anend 127, a second loop 130 as a part of a second cord 135 having an end137, a first extension member 110, a second extension member 150, and anadaptor 160. The first extension member 110 includes an opening 113through which the first loop 120 or cord 125 exits, and the secondextension member 150 includes an opening 153 through which the secondloop 130 or cord 135 exits. It will be understood that openings 113, 153may be positioned in at any suitable location of the extension members110, 150 and the locations depicted in FIG. 7 is merely for purposes ofexample. The first 125 and second 135 cords extend through the extensionmembers adaptor and shaft such that an end 127, 137 of the cords extendsbeyond the shaft 210. The end portions 127, 137 of the cords 125, 135are configured to be coupled to one or more actuation mechanisms (notshown) that are configured to control constriction and expansion of theloops 120, 130. The shaft 210 may include one or more lumens throughwhich the cords may extend.

A shaft may have any suitable number of lumens. In some embodiments, ashaft has a single lumen through which all the cords extend. In someembodiments, a shaft has a sufficient number of lumens for each cord toextend through a separate lumen. In some embodiments, more than one cordextends through a lumen of a shaft.

Referring now to FIG. 8, an embodiment of a holder 100 and delivery toolor system 200 are shown. The embodiment depicted in FIG. 8 is similar tothe embodiment depicted in FIG. 7, with like numbers referring to likecomponents. In FIG. 8, the delivery tool 200 includes a handle 220having actuation elements 230, 240 operably coupled to a tensionapparatus configured to control constriction and expansion of loops 120,130. Handle 220 is attached to shaft 210 or handle 220 and shaft 210 maybe formed as a single component. The shaft 210 and handle 220 aresufficiently rigid or have sufficiently rigid components to allow a userto grasp the handle or shaft and direct a self-expanding medical deviceto a desired implant location. In the depicted embodiments, the handlehas two actuation elements 230, 240 (each independently coupled to aseparate tension apparatus) so that one actuation element may controlone loop and the other actuation element may control the other loop.

In some embodiments, more than one loop can be controlled by a singleactuation element.

Referring now to FIG. 9, an embodiment of a holder 100 and delivery toolor system 200 are shown. The embodiment depicted in FIG. 9 is similar tothe embodiment depicted in FIGS. 7 and 8, with like numbers referring tolike components. In FIG. 9, the delivery tool 200 includes a controlunit 260 attached to handle 220 via a tether 250. The control unit 260includes actuation elements 230, 240 (operably coupled to tensionapparatus that may be housed in, for example, the handle or the controlunit) for controlling constriction and expansion of loops 120, 130. Atool 200 as depicted in FIG. 9 allows for one to position theself-expanding medical device (which would be retained by holder 100)with one hand and to control constriction and expansion of loops 120,130 via actuation elements 230, 240 with another hand. Alternatively,one person could position the device at the proper implant location bygrasping the shaft 210 or handle 220 and another could control the loops120,130 via actuation elements 230, 240 of control unit 260. In someembodiments, the cords (not shown in FIG. 9) are coupled with actuationelements 230, 240 in the control unit 260. In some embodiments, thecords are coupled with a portion of an actuation assembly that is a partof the handle or shaft, which portions of the actuation assembly arecontrolled via actuation elements actuation elements 230, 240 in thecontrol unit 260.

The discussion above with regard to FIGS. 1-9 is intended to be genericwith regard to devices that may be implanted and holders and deliverytools for implanting the devices. It will be understood that theaspects, components, or both the aspects or components depicted in ordiscussed with regard to FIGS. 1-9 are interchangeable. For example, adiscussion above with regard to FIG. 1A may also apply to a discussionwith regard to FIG. 9 as appropriate, and vice-versa.

In some embodiments, a device implantable using a holder or deliverysystem as described herein is a self-expanding device or a device havinga self-expanding component that is configured to be implanted in anative valve of a subject. In various embodiments, the device comprisesa frame having an annular portion configured to be aligned with theannulus of the native valve. In some embodiments, the device to beimplanted is a prosthetic heart valve.

The frame, in some embodiments, is expandable from a collapsedconfiguration to an expanded configuration in a controlled manner usinga holder or delivery system as described herein. In the expandedconfiguration in some of such embodiments, the annular portion of theframe is configured to engage the annulus of the native valve. The framemay be configured to be at least partially collapsed from the expandedconfiguration to an at least partially collapsed configuration using aholder or delivery system described herein such that the frame can berepositioned during an implant procedure if the frame is not properlyaligned with the annulus of the native valve.

In some embodiments, the frame has a flange positioned superior to theannular portion when implanted, wherein the flange is compressible andexpandable. The flange may be a part of a concave-shaped portionconfigured to anchor the device around the annulus. In some embodiments,at least one loop of a holder is positioned around at least a portion ofthe flange to control expansion of the flange during an implantprocedure.

II. Anatomical Features of a Valve and Examples of Prosthetic HeartValves

Prior to describing specific embodiments of holders and delivery systemsthat may be advantageously employed for delivering prosthetic heartvalves to a heart valve of a patient, a general description of heartvalve device components and heart valve anatomy is provided with regardto FIGS. 10-19.

FIGS. 10A and 10B generally illustrate one exemplary embodiment of aheart valve 1. As illustrated in FIG. 10, valve 1 includes a distaloutflow end 2, a plurality of leaflets 3, and a proximal inflow end 4. Atypical valve functions similar to a collapsible tube in that it openswidely during systole or in response to muscular contraction to enableunobstructed forward flow across the valvular orifice, as illustrated inFIG. 10A. In contrast, as forward flow decelerates at the end of systoleor contraction, the walls of the tube are forced centrally between thesites of attachment to the vessel wall and the valve closes completelyas illustrated in FIG. 10B.

FIGS. 11A, 11B, and 11C illustrate the anatomy of a typical aorticvalve. In particular, FIG. 11A shows a top view of a closed valve withthree valve sinuses, FIG. 11B shows a perspective sectional view of theclosed valve, and FIG. 11C shows a view from outside the vessel wall.

One consideration in the design of valve replacement systems and devicesis the architecture of the valve to be replaced. For example, mitral andtricuspid heart valves do not have valve sinuses whereas aortic andpulmonic heart valves have valve sinuses. Valve sinuses 12 are dilationsof the vessel wall that surround the natural valve leaflets. Typicallyin the aortic valve, each natural valve leaflet has a separate sinusbulge 12 or cavity that allows for maximal opening of the leaflet atpeak flow without permitting contact between the leaflet and the vesselwall. As illustrated in FIGS. 11A, 11B, and 11C, the extent of the sinus12 is generally defined by the commissures 11, vessel wall 13, inflowend 14, and outflow end 15. The proximal intersection between the sinuscavities define the commissures 11.

FIGS. 11B and 11C also show the narrowing diameter of the sinuses atboth inflow end 14 and outflow end 15, thus forming the inflow andoutflow annuli of the sinus region. Thus, the valve sinuses form anatural compartment to support the operation of the valve by preventingcontact between the leaflets and the vessel wall, which, in turn, maylead to adherence of the leaflets and/or result in detrimental wear andtear of the leaflets. The valve sinuses are also designed to share thestress conditions imposed on the valve leaflets during closure whenfluid pressure on the closed leaflets is greatest. The valve sinusesfurther create favorable fluid dynamics through currents that soften anotherwise abrupt closure of the leaflets under conditions of highbackflow pressure. Lastly, the sinuses ensure constant flow to anyvessels located within the sinus cavities.

FIG. 12 is a schematic representation of the geometry and relativedimensions of the valve sinus region. As shown in FIG. 12, the valvesinus region is characterized by certain relative dimensions whichremain substantially constant regardless of the actual size of thesinuses. Generally, the diameter of the sinus is at its largest at thecenter of the sinus cavities 16, while there is pronounced narrowing ofthe sinus region at both the inflow annulus 17 near the inflow end 14and the outflow annulus 18 near the outflow end 15. Furthermore, theheight of the sinus 19 (i.e. the distance between inflow annulus 17 andoutflow annulus 18) remains substantially proportional to its overalldimensions. It is thus apparent that the sinus region forms ananatomical compartment with certain constant features that are uniquelyadapted to house a valve. The systems and devices disclosed herein maybe designed to utilize these anatomical features of the native sinusregion for replacement valve function and positioning.

FIG. 13 is a perspective view of a valve replacement system 20 describedin more detail in US Published Patent Application No. 2010/0168844(which application is hereby incorporated by reference in its entiretyto the extent that it does not conflict with the disclosure presentedherein), which contains general features of the valves described in moredetail below. Such valves, as well as the valve depicted in FIG. 4,include replacement valve 22, valve support structure or frame 24, andvalve cuff 26. Replacement valve 22 may be attached to frame 24 suchthat replacement valve 22 resides within the support structure. Valvesupport structure 24 may be, for example, an expandable and collapsiblestent-like frame structure adapted to be delivered to an implantationsite such as a native heart valve. Frame 24 may be either self-expandingor non-self-expanding, and may be delivered to the target site via anysuitable delivery means as will be appreciated by one skilled in theart. Valve cuff 26 is attachable to the inflow end of replacement valve22, and may be structured to reduce paravalvular leakage around thevalve, as well as to reduce migration and increase stability ofreplacement valve 22 after implantation at the implantation site.

Replacement valve 22 illustrated in FIG. 13 is a tri-leaflet valve. Forpurposes of example and not limitation, the following discussion willreference only valve 22, it being understood that any stented orstentless replacement valve is contemplated. Similarly, although valveframe 24 is shown as structured to receive a tri-leaflet valve, thoseskilled in the art will appreciate that replacement valves having anumber of leaflets other than three will correspondingly require adifferent valve support structure.

FIG. 14 is a perspective view of replacement valve 22, which representsone exemplary embodiment of a tri-leaflet replacement valve useable withvalve replacement systems 20 described herein. Replacement valve 22includes valve body 30 having proximal inflow end 31 and a distaloutflow end 32. Valve body 30 includes a plurality of valve tissueleaflets 33 joined by seams 34, wherein each seam 34 is formed by ajunction of two leaflets 33. A commissural tab region 35 extends fromeach seam 34 at the distal end of valve body 30. Inflow end 31 of valvebody 30 includes a peripheral edge that may be scalloped or straight. Inaddition, inflow end 31 of valve body 30 may further comprisereinforcement structure 36 that may be stitched or otherwise attachedthereto.

The valve replacement systems and devices described herein are notlimited, however, to the specific valve illustrated in FIG. 14. Forexample, although the proximal inflow end 31 of valve body 30 is shownin FIG. 14 with a scalloped peripheral edge, other shapes andconfigurations are contemplated and within the intended scope of thepresent disclosure.

Valve leaflets 33 may be constructed of any suitable material, includingbut not limited to polymeric materials, metallic materials, and/ortissue-engineered materials. For example, bovine, porcine, equine,ovine, and/or other suitable animal tissues may be used to constructvalve leaflets. In some embodiments, valve leaflets may be constructedof or formed from material obtained from, for example, heart valves,aortic roots, aortic walls, aortic leaflets, pericardial tissue, bloodvessels, intestinal submucosal tissue, umbilical tissue and the likefrom humans or animals. In some embodiments, valve leaflets may beconstructed of expanded polytetrafluoroethylene (ePTFE), equinepericardium, bovine pericardium, or native porcine valve leafletssimilar to currently available bioprosthetic aortic valves. Othermaterials may prove suitable as will be appreciated by one skilled inthe art.

FIG. 15 is a side view of valve support structure 24, which representsone exemplary embodiment of a typical support structure useable withvalve replacement system 20 in accordance with the teaching presentedherein. In general, valve support structure 24 is designed as acollapsible and expandable anchoring structure that may be adapted tosupport valve 22 distally along commissural tab region 35 and proximallyalong the proximal inflow end 31. As shown in FIG. 15, valve 22 andvalve cuff 26 have been detached from valve frame 24 so as to focus onthe structure and features of the support structure.

In some embodiments, valve frame 24 has a generally tubularconfiguration within which replacement valve 22 may be secured, andincludes inflow rim 41, support posts 42 and outflow rim 43. Replacementvalve 22 may be secured at the proximal inflow end 31 by attachment toinflow rim 41 of support structure 24 and at the distal outflow end 32via commissural tabs 35 that are threaded through axially extendingslots 44, which are formed in support posts 42 that extendlongitudinally from inflow rim 41 to outflow rim 43 of valve supportstructure 24. Thus, distal ends 45 of support posts 42 contact outflowrim 43 of valve support structure 24, whereas proximal ends 46 ofsupport posts 42 contact inflow rim 41 of valve support structure 24.

In the embodiment shown in FIG. 15, outflow rim 43 of support structure24 is depicted as comprising a plurality of rings that extend betweensupport posts 42 generally at or above the axially extending slots 44that reside therein. The plurality of rings of outflow rim 43 areconfigured in an undulating or zigzag pattern forming peaks 47 andvalleys 48, wherein the individual rings remain substantially parallelto one another. The plurality of rings of outflow rim 43 may include avertical connector element 49 positioned at the center of valleys 48formed by the undulating or zigzag pattern. Vertical connector element49 is designed to stabilize frame 24 and to prevent distortion of thevalve during compression and expansion of the frame. Vertical element 49extends longitudinally in the axial direction of the cylindrical valvesupport structure 24.

In the embodiment of valve support structure 24 illustrated in FIG. 15,outflow rim 43 is formed with two rings, while inflow rim 41 is formedwith a single ring that extends between support posts 42. However, thenumber of rings is not important, and numerous other configurations arecontemplated.

Both inflow rim 41 and outflow rim 43 of valve support structure 24 areformed with an undulating or zigzag configuration. In variousembodiments of valve support structures, inflow rim 41 may have ashorter or longer wavelength (i.e., circumferential dimension from peakto peak) and/or a lesser or greater wave height (i.e., axial dimensionfrom peak to peak) than outflow rim 43. The wavelengths and wave heightsof inflow rim 41 and outflow rim 43 may be selected to ensure uniformcompression and expansion of valve support structure 24 withoutsubstantial distortion. The wavelength of inflow rim 41 is furtherselected to support the geometry of the inflow end of the valve attachedthereto, such as the scalloped inflow end 31 of replacement valve 22shown in FIG. 14. Notably, as shown in FIG. 15, the undulating or zigzagpattern that forms inflow rim 41 of valve support structure 24 isconfigured such that proximal ends 46 of vertical support posts 42 areconnected to peaks 50 of inflow rim 41. Similarly, the undulating orzigzag pattern that forms outflow rim 43 of support structure 24 isconfigured such that distal ends 45 of support posts 42 are connected tovalleys 48 of outflow rim 43. Locating distal ends 45 of support posts42 at valleys 48 of outflow rim 43 may prevent the longitudinalextension of outflow rim 43 in the direction of replacement valve 22secured within the lumen of valve support structure 24 upon compressionof the replacement valve assembly 20. As a result, most, if not all,contact between replacement valve 22 and valve support structure 24 iseliminated. Likewise, locating proximal ends 46 of support posts 42 atpeaks 50 of inflow rim 41 may prevent longitudinal extension of inflowrim 41 in the direction of the valve tissue. Thus, compression ofreplacement valve 22 and valve support structure 24 does not lead todistortion of or injury to the valve.

FIG. 15 further shows that support posts 42 are configured generally inthe shape of a paddle with axial slot 44 extending internally withinblade 51 of the paddle. Blade 51 of the paddle is oriented towardoutflow rim 43 of support structure 24 and connects to outflow rim 43 ata valley 48 of the undulating or zigzag pattern of outflow rim 43. Animportant function of support posts 42 is the stabilization of valve 22in general, and in particular the prevention of any longitudinalextension at points of valve attachment to preclude valve stretching ordistortion upon compression of replacement valve system 20. Blades 51 ofthe paddle-shaped support posts 42 may be designed to accommodatecommissural tabs 35 of valve 22.

Support posts 42 further comprise triangular shaped elements 52extending on each side of proximal end 46 of the support post.Triangular shaped elements 52 may be designed to serve as attachmentssites for valve cuff 26 and may be designed in different shapes withoutlosing their function. Thus, the particular design of elements 52 shownin FIG. 15 is not critical to the attachment of valve cuff 26, andnumerous other designs and shapes are contemplated and within theintended scope of the present disclosure.

The number of support posts 42 generally ranges from two to four, andgenerally depends on the number of commissures and leaflets present inthe replacement valve 22. Thus, valve support structure 24 may comprisethree support posts for a tri-leaflet replacement valve 22. Supportposts 32 of valve frame 24 may be structured to generally coincide withthe natural commissures of the native valve being replaced.

Valve frame 24 may be formed from any suitable material including, butnot limited to, stainless steel or nitinol. The particular materialselected for valve support structure 24 may be determined based uponwhether the support structure is self-expanding or non-self-expanding.For example, preferable materials for self-expanding support structuresinclude shape memory materials, such as nitinol.

FIG. 16 is a side view illustrating replacement valve device 20 of FIG.13, which once again includes replacement valve 22, valve support frame24, and valve cuff 26. As shown in the embodiment depicted in FIG. 16,valve 22 is secured at the proximal inflow end 31 by attachment toinflow rim 41 of valve frame 24 and at the distal outflow end 32 viacommissural tabs 35 that are threaded through axially extending slots 44formed in support posts 42. Notably, as can be seen in the embodimentshown in FIG. 16, outflow rim 43 of frame 24 is structured to belongitudinally displaced from the distal outflow end 32 of valveleaflets 33 that reside within the lumen of the tubular valve frame 24.Thus, contact between valve leaflets 33 and frame 24 is avoided.

The positioning of replacement valve 22 internally to frame 24 with onlycommissural mounting tabs 35 of replacement valve 22 contacting supportposts 42 at the distal outflow end 32 of the valve, while the proximalinflow end 31 of the valve is separated from inflow rim 41 of valvesupport structure 24 by valve cuff 26, ensures that no part ofreplacement valve 22 is contacted by frame 24 during operation of valve22, thereby eliminating wear on valve 22 that may be otherwise resultfrom contact with mechanical elements.

As shown in FIG. 16, valve cuff 26 generally includes skirt 60 andflange 62. As illustrated in FIG. 16, skirt 60 may be structured tocover the outer surface of valve support structure 24, such as along theproximal inflow end 31. In particular, skirt 60 of valve cuff 26 wrapsaround the entire circumference of replacement valve 22 and frame 24near the proximal inflow end 31 and inflow rim 41, respectively.Furthermore, as shown in FIG. 16, skirt 60 may have a generallyscalloped configuration so as to substantially align with the scallopsfound in or around the native valve implantation site and with thescalloped configuration of replacement valve 22. However, one skilled inthe art will appreciate that valve cuffs with non-scalloped skirts arealso contemplated and within the intended scope of the presentdisclosure.

Skirt 60 of valve cuff 26 is designed to provide numerous benefits whenused in conjunction with a replacement valve such as replacement valve22. First, skirt 60 functions to protect the proximal inflow end 31 ofreplacement valve 22 from irregularities of a valve annulus such that,for example, calcification remnants or valve remnants left behind aftera native valve removal procedure do not come into contact with anyportion of replacement valve 22. If otherwise allowed to contactreplacement valve 22, these remnants impose a risk of damage to thevalve. Second, when positioned adjacent a native valve annulus, skirt 60provides another source of valve sealing, and also assists valve cuff 26to conform to irregularities of the native valve annulus. Third, oncevalve cuff 26 is positioned adjacent a native valve annulus, skirt 60allows tissue ingrowth into the valve cuff. Such tissue ingrowth notonly improves the seal provided by valve cuff 26, but also helps toanchor the valve cuff to the native valve annulus and minimize migrationof replacement valve system 20 after implantation. Skirt 60 of valvecuff 26 may provide addition benefits other than those previouslydiscussed as will be appreciated by those skilled in the art.

As illustrated in FIG. 16, flange 62 of valve cuff 26 is coupled toskirt 60 and is structured to protrude from replacement valve device 20around the entire circumference of the valve. Once replacement valvesystem 20 is delivered to an implantation site and deployed, valvesupport structure 24 exerts a radial force within valve cuff 26 whichpushes flange 62 against native tissue at the implantation site, therebycreating a seal to prevent paravalvular leakage and migration ofreplacement valve device 20 within the aorta. For example, inembodiments where valve support structure 24 is formed from a memoryshaped metal, the radial force may result from the support structure“springing” back to expanded form after deployment at the implantationsite.

Flange 62 of valve cuff 26 is structured for forming a seal between theproximal inflow end 31 of replacement valve 22 and the annulus of thenative valve site. In some embodiments, if one or more native valvestructures are removed from a patient's body prior to implantation ofthe replacement valve device 20, irregularities may exist around theannulus of the native valve site. These irregularities may be the resultof, for example, natural calcifications or valve remnants left over fromextraction of the native valve. Irregularities around the annulus can beproblematic because they can contribute to paravalvular leakage.

In the past when irregularities were present, it was difficult tomaintain a tight seal between the native valve annulus and thereplacement valve. However, flange 62 of valve cuff 26 is structured toconform to irregularities around the native valve annulus, thusimproving the seal between replacement valve 22 and the native valveannulus. As a result, paravalvular leakage around the replacement valvemay be reduced or eliminated.

FIG. 17 is a view of replacement valve system 20 positioned within anaortic valve, which includes native valve annulus 64. As shown in FIG.17, valve frame 24 has expanded within the native valve annulus 64,thereby forcing flange 62 of valve cuff 26 against native valve annulus64 to form a tight seal between replacement valve 22 and the nativevalve annulus 64 so as to prevent or at least minimize paravalvularleakage and migration of replacement valve 22 from the implantationsite. Thus, with flange 62 in contact with native annulus 64, valve cuff26 acts as a gasket to seal the junction between replacement valvesystem 20 and the native valve annulus 64.

In one embodiment, an adhesive may be applied to valve cuff 26 prior toimplantation within a native valve annulus. For example, any suitablebiocompatible adhesive may be applied to the outer surfaces of skirt 60and flange 62 to help seal valve cuff 26 to the surrounding tissue ofthe valve annulus. While not a necessary component, biocompatibleadhesives may help to provide a tighter seal in order to further reduceparavalvular leakage.

In other embodiments, the flange 62 valve cuff 26 may be constructedwith a memory shaped or deformable material disposed within the flangethat helps to create a tight seal with the native valve annulus. Inparticular, the memory shaped or deformable material may be structuredto expand once valve cuff 26 is properly positioned at the implantationsite. This type of valve cuff flange may be utilized regardless ofwhether the valve support structure is of the self-expanding ornon-self-expanding type.

In some embodiments, both skirt 60 and flange 62 of valve cuff 26 can beformed from a cloth or fabric material. The fabric may comprise anysuitable material including, but not limited to, woven polyester such aspolyethylene terepthalate, polytetrafluoroethylene (PTFE), or otherbiocompatible material.

In one exemplary embodiment of assembling valve replacement system 20,skirt 60 and flange 62 are formed as separate components that arecoupled together in order to form valve cuff 26. In particular, skirt 60may initially be positioned around and coupled to valve support frame 24in any suitable manner, such as by suturing. For example, each skirtattachment portion 63 may be wrapped around a corresponding support post42 of valve frame 24. Skirt attachment portions 63 may then, forexample, be sutured to triangular shaped attachment sites 52 near theproximal ends 46 of each of the support posts 42. Then, flange 62 may bepositioned at the desired position around skirt 60 and coupled to theskirt by any suitable means, such as by suturing. Next, replacementvalve 22 may be positioned within the inner lumen of frame 24, insertingcommissural tab portions 35 of replacement valve 22 throughcorresponding axially extending slots 44 in support posts 42. Skirt 60of valve cuff 26, which is positioned circumferentially around inflowrim 41 of frame 24, may then be wrapped around the proximal inflow end31 of replacement valve 22 and attached to the valve with, for example,sutures. Once attached, skirt 60 and flange 62 are structured to createtight, gasket-like sealing surfaces between replacement valve 22 and thenative valve annulus. The foregoing represents only one exemplaryembodiment of a method of assembling a valve replacement system inaccordance with the present disclosure. Thus, modifications may be madeto the number and order of steps as will be appreciate by one skilled inthe art.

Referring now to FIG. 18A, a frame 24 of a prosthetic valve may includea concave landing zone, e.g., as described in U.S. Patent ApplicationPublication No. 2010/0100176, entitled ANCHORING STRUCTURE WITH CONCAVELANDING ZONE, which published patent application is hereby incorporatedherein in its entirety to the extent that it does not conflict with thedisclosure presented herein. The frame 24 in FIG. 18A is illustrated ascut along line A-A and laid flat. The frame 24 in FIG. 18A representsone exemplary embodiment of a typical anchoring or support structureuseable with valve replacement system 20 described herein. In general,frame 24 is designed as a collapsible and expandable anchoring structureadapted to support a valve distally along commissural region andproximally along the proximal inflow end. As shown in FIG. 18A, valvehas been detached from support frame 24 so as to focus on the structureand features of the support structure.

Frame 24 has a generally tubular configuration within which areplacement valve may be secured, and includes inflow rim 41, supportposts 42 and outflow rim 43. A replacement valve may be secured at theproximal inflow end 31 by attachment to inflow rim 41 of support frame24 and at the distal outflow end 32 via commissural tabs 35 that arethreaded through axially extending slots 44, which are formed in supportposts 42 that extend longitudinally from inflow rim 41 to outflow rim 43of valve support structure 24. Thus, distal ends 45 of support posts 42contact outflow rim 43 of valve support structure 24, whereas proximalends 46 of support posts 42 contact inflow rim 41 of frame 24.

As shown in FIG. 18A outflow rim 43 of support frame 24 is depicted ascomprising a single wire ring or rail that extends between support posts42 generally at or above the axially extending slots 44 that residetherein. The outflow rim 43 is configured in an undulating or sinusoidalwave pattern forming peaks 47 and troughs 48. However, the number ofrings is not important, and numerous other configurations arecontemplated and may be utilized such as single, double and tripleconfigurations of varying patterns. Inflow rim 41 is depicted ascomprising a double wire ring or rail that includes a distal inflow wirering 49 and a proximal inflow wire ring 51. Distal inflow wire ring 49and proximal inflow wire ring 51 are configured in an undulating orsinusoidal wave pattern forming peaks 47 and troughs 48. As can be seen,the double wire rail is configured so that a peak of proximal inflowwire ring 51 connects with a trough of distal inflow wire ring 51 thusforming a diamond pattern although any number of desired shapes may beachieved such as pentagonal, hexagonal, rectangular, etc., all of whichare within the scope of the disclosure presented herein.

The inflow rim 41 optionally includes finger-like elements 53 positionedat which distal and proximal inflow wire rings 49, 51 connect and extendin an axial direction therefrom. Finger-like elements 53 are designed tolend additional support to fabric that may cover inflow rim 41 to anchorthe fabric and permit tissue ingrowth.

In the embodiment of support frame 24 illustrated in FIG. 18A, outflowrim 43 is formed with a single ring, while inflow rim 41 is formed witha double ring that extends between support posts 42. However, the numberof rings may vary, and numerous other configurations are contemplated.

Both inflow rim 41 and outflow rim 43 of frame 24 may be formed with anundulating or sinusoidal wave-like configurations. In variousembodiments of valve support structures, inflow rim 41 may have ashorter or longer wavelength (i.e., circumferential dimension from peakto peak) or a lesser or greater wave height (i.e., axial dimension frompeak to peak) than outflow rim 43. The wavelengths and wave heights ofinflow rim 41 and outflow rim 43 may be selected to ensure uniformcompression and expansion of support frame 24 without substantialdistortion. The wavelength of inflow rim 41 may be further selected tosupport the geometry of the inflow end of the valve attached thereto,such as the scalloped inflow end 31 of replacement valve 22 shown inFIG. 18. Notably, as shown in FIG. 18A, the undulating or sinusoidalwave pattern that forms inflow rim 41 of frame 24 may be configured suchthat proximal ends 46 of vertical support posts 42 are connected totroughs 48 of inflow rim 41. Similarly, the undulating or sinusoidalwave-like pattern that forms outflow rim 43 of support structure 24 maybe configured such that distal ends 45 of support posts 42 are connectedat a peak 47 of outflow rim 43. This arrangement allows the distalinflow wire ring and proximal inflow wire ring to move together when thevalve is in its radially compressed state prior to delivery thuspreventing possible damage to the bioprosthetic heart valve.

In the embodiment depicted in FIG. 18A the distal ends 45 of supportposts 42 are configured generally in the shape of a paddle with axialslot 44 extending internally within blade 51 of the paddle. Blade 51 ofthe paddle is oriented toward outflow rim 43 of support structure 24 andconnects to outflow rim 43 at a peak of the undulating sinusoidalwave-like pattern of outflow rim 43. Support posts 42 stabilize a valvein general, and in particular the prevention of longitudinal extensionat points of valve attachment to preclude valve stretching or distortionupon compression of replacement valve system. Blades 51 of thepaddle-shaped support posts 42 are also designed to accommodatecommissural tabs of a valve.

The number of support posts 42, if present, generally ranges from two tofour, depending on the number of commissural posts present in the valvesinus. Thus, in some embodiments, valve support structure 24 comprisesthree support posts for a tri-leaflet replacement valve with a nativevalve that features three natural commissures. Support posts 42, ifpresent, of frame 24 may be structured to generally coincide with thenatural commissures of a native valve.

Turning now to FIG. 18B a cross-sectional view of the inflow rim 41 isdepicted which illustrates the concave landing zone 60. As can be seen,peaks 47 of the distal inflow ring 49 and troughs 48 of the proximalinflow ring 51 flare outwardly so that inflow rim 41 forms a C-shape incross section upon deployment. This cross-sectional area 61 of theinflow rim 41, or in other words the concave portion of the frame,directly corresponds to the native annulus. The frame of the inflow rimengages the native annulus, with the flared rails 47, 48 lying above andbelow the annulus. Upon deployment, the radial force exerted by theself-expanding frame holds the valve in position.

The concave landing zone 61 substantially prevents paravalvular leakage.Paravalvular leakage may be reduced by ensuring the inflow rim 41 issubstantially secured proximally and distally of the annulus, henceforming a tight seal. Concave landing zone 60 allows the surgeon toeasily place the bioprosthetic heart valve in the annulus thusminimizing patient time spent in surgery.

FIG. 19 is a view of replacement valve system 20 positioned within anative valve anatomical structure, which includes inflow annulus 64 andoutflow annulus 66. As shown in FIG. 10, the tubular anchoring structure24 of FIG. 18A has expanded within the sinus cavities of native valvelocation, thereby forcing inflow rim 41 against inflow annulus 64 of thenative valve anatomy to form a tight seal between replacement valvesystem 20 and native valve anatomy. More specifically, upon deploymentinflow rim 41 assumes a substantially C-shaped in cross section concavelanding zone 60 as can be seen in FIGS. 18B and 10. Distal inflow ring49 abuts the distal side of the annulus while proximal inflow ring 51abuts the proximal side of the native annulus. The concave landing zone60 prevents or minimizes paravalvular leakage and migration ofreplacement valve system 20 from the implantation site. Thus, withinflow ring 41 in contact with inflow annulus 64, the concave landingzone 60 acts as a gasket to seal the junction between replacement valvesystem 20 and native anatomy. Typically, inflow ring 41 is covered withfabric to stimulate tissue ingrowth over time and secure the replacementheart valve in position. The fabric may comprise any suitable materialincluding, but not limited to, woven polyester, polyester velour,polyethylene terepthalate, polytetrafluoroethylene (PTFE), or otherbiocompatible material. The valve assembly may be compressed in ice,loaded into a delivery system, and deployed into the aortic valveposition. The self-expanding characteristic of the anchoring structureprovides the radial strength required to hold the valve in positionafter implant.

Although the above disclosure focused on a tri-leaflet replacement valvedevice 20, valve cuffs in accordance with the present disclosure may beused in conjunction with any type of replacement valve of generallysimilar structure, including but not limited to the heart valvesdisclosed in U.S. application Ser. No. 10/680,071, U.S. application Ser.No. 11/471,092, and U.S. application Ser. No. 11/489,663, allincorporated herein in their entirety to the extent that they do noconflict with the disclosure presented herein. Therefore, the valve cuffconcepts disclosed herein may be applied to valve cuffs structured tofunction with many other types of replacement valves having any numberof leaflets without departing from the spirit and scope of the presentdisclosure.

Furthermore, although the above disclosure focuses on frame 24 having aninflow rim 41, an outflow rim 43, and three support posts 42, thisparticular valve support structure was described merely for purposes ofexample and not limitation. Thus, valve cuffs in accordance with thepresent disclosure may be used in conjunction with any generallytubular, stent-like valve support structure, as will be appreciated byone skilled in the art.

Additional designs of prosthetic heart valves that may be employed withthe delivery systems and associated devices described herein includethose designs disclosed in U.S. Provisional Patent Application No.61/819,486 filed on May 3, 2013, and those disclosed in U.S. patentapplication Ser. No. ______, entitled PROSTHETIC VALVES AND ASSOCIATEDAPPARATUSES, SYSTEMS AND METHODS, having attorney docket numberC00005661.USU3, filed on the same day as the present application, whichpatent applications are each hereby incorporated herein by reference intheir respective entireties to the extent that they do not conflict withthe disclosure presented herein. Heart valves may have markings tofacilitate implant and provide visual feedback regarding implant depthor orientation such as described in, for example, (i) U.S. ProvisionalPatent Application No. 61/930,851, filed on Jan. 23, 2014; (ii) U.S.Provisional Patent Application No. 61/819,486 filed on May 3, 2013; and(iii) U.S. patent application Ser. No. ______, entitled MEDICAL DEVICESFOR IMPLANTING IN A VALVE AND ASSOCIATED METHODS, filed on the same dayas the present application, each of which patent applications are herebyincorporated herein by reference in their respective entireties to theextent that they do not conflict with the disclosure presented herein

In embodiments, replacement valve systems described herein aresutureless valve systems. Of course, sutures may be used with suchsystems. Advantages to sutureless replacement valve systems includeshorter implant procedure times and less invasive implantation. Somedisadvantages or perceived disadvantages with current sutureless valvesystems include potential increased risk of paravalvular leakage (PVL)and potential lack of durability. The designs presented hereinpreferably address one or more of the disadvantages or perceiveddisadvantages of current sutureless valve designs.

III. Systems and Devices for Retention or Delivery of Prosthetic HeartValves

Various embodiments of a holder and delivery system for a valvereplacement system are described below. In some embodiments, the holdersand delivery systems provide a solution to inaccurate placement orinsufficient visibility often associated with valve delivery systems,particularly delivery systems for delivering sutureless prostheticvalves.

Of importance to the implantation process is the valve replacementsystem and delivery system packing configurations. In some embodiments,the valve is packaged with a holder, one or more cords (which mayinclude cinch sutures forming loops and tethers), and an adapter tomanage the cords and to prevent tangling. In some embodiments, thedelivery system is packaged separately with a crimping funnel and anyother accessories.

In FIGS. 20-42 and 53-74 below, a number of embodiments of heart valves,holders and delivery systems are described. In many aspects thecomponents presented in, or discussed with regard to, FIGS. 20-42 and53-74 are similar to those presented in, or discussed above with regardto, FIGS. 1-9, with like numbers referring to similar components. Use ofdifferent numbers in the figures does not necessarily mean that thelabeled systems, devices, or components are dissimilar or cannot be thesame.

Referring now to FIGS. 20A-B, an embodiment of a holder 100 and aprosthetic heart valve 20 having a self-expanding frame 24 is shown. Inthe depicted embodiment, the holder has three extensions 110, 150, 170that extend from adapter 160 into a central opening of the device 20. Atthe distal end portions of the extensions, conduits (e.g., conduit 113of extension 110) are formed through the extensions for management ofcords (e.g., cord 125). In the depicted embodiment, there is one cordfor each extension. While not readily apparent from the drawings, eachcord (e.g., cord 125) is disposed around about one-third of thecircumference of an upper portion 72 of the inflow region 70 of theprosthetic heart valve device 20. Together, the three cords extendsubstantially around the upper portion 72 of the inflow region 70. Insuch embodiments, all of the cords are preferably dependently controlledsuch that the loops (e.g., loop 120 of first cord 125) are constrictedor expanded together via tension. While not depicted, it will beunderstood that a single loop may extend around the upper inflow portion72 or that other loops may extend around at least a portion of otherregions such as the lower portion 74 of the inflow region 70 or anoutflow portion of the device or frame.

In some embodiments, a cord positioned around an inflow region of aprosthetic valve may pass through a skirt one or more times. Passing acord through the skirt may result in undesirable puckering of the skirt.With smaller bites (passing in and out of the skirt at shorterintervals) results in less puckering. In various embodiments, a cordpasses in and out of a skirt at an interval of 2 mm or less. Preferably,the bites occur at locations of flared structures of the frame toprevent the cord from sliding down when the valve is warmed.

In some embodiments, a cord is positioned around an outflow portion of aprosthetic valve in a manner such that the cord does not slide off ofthe top of the valve. In some embodiments, the cord is passed throughone or more fabric pieces that are assembled to the valve outflow region(e.g., at the commissures). In some embodiments, hooks or flaredportions are formed into the outflow end of the frame to capture thecord.

In FIG. 20A, the device 20 is shown in an expanded configuration. Asshown the inflow region 70 is concave when the frame 24 is expanded withthe upper 74 and lower 72 portions of the inflow region 70 formingflanges configured to engage and help seal (along with skirt 60) thedevice about an annulus of a valve sinus. In FIG. 20B the device isshown in a constricted configuration.

A cord management assembly 300 is also depicted in FIGS. 20A-B. The cordmanagement system 300 includes a spool 310 around which the cords arewrapped and a block 320 to which the cords may be attached.

Nearly any embodiment described herein can include a cord managementassembly, such as the assembly depicted in FIGS. 20A and 20B. Inclusionof a cord management assembly can serve to manage cords during shippingand/or crimping prior to connecting the holder to the delivery system.In embodiments, the tether management component comprises a coil aroundwhich the tether sutures are wound and to which the tether connectionadapter is mounted. This may allow for the prosthetic valve to becrimped without the user managing a bird's nest of cords. The cordmanagement assembly may, in some embodiments, be discarded when theprosthetic valve is ready to be connected to the delivery system.

Referring now to FIGS. 21A-D, an embodiment of a holder 100, prostheticheart valve 20 and delivery system (or portions thereof) are shown atvarious stages of an implant procedure. The holder 100 and prostheticheart valve 20 are the same as depicted in FIGS. 20A-B, with likenumbers referring to like components.

As shown in FIG. 21A, a shaft 210 of a delivery system is coupled to theadaptor of the holder 100. The prosthetic heart valve device 20 isinserted into a native valve until an appropiate portion of the inflowregion of the device 20 is aligned with the annulus 14 of the nativevalve via holder 100 and delivery system. The valve device 20 isinserted in a constricted (e.g., crimped) configuration. Tension isplaced on cords forming loops 120, 130, 140 to retain the upper inflowportion 74 in a constricted configuration.

As shown in FIG. 21B, while tension is retained on cords forming loopsto constrict upper inflow portion 74 other portions (e.g., lower portion72 of inflow region and outflow region 80) are expanded or allowed toexpand. In some embodiments, the frame is expanded by heating the frame;e.g., with warm water or saline. If the device 20 is inserted to anappropriate depth, expansion of the lower portion 72 of the inflowregion should prevent withdrawal of the device 20 past the annulus 14.If the device 20 appears to be properly positioned or is moved to beproperly positioned after expansion of the lower portion 72 of theinflow region, the upper portion 74 of the inflow region may be allowedto expand by loosening tension of the cords to allow the loops 120, 130,140, and thus the upper inflow portion 74, to expand (FIG. 21C). Withexpansion of upper inflow portion 74 and lower inflow portion 72, thedevice 20 securely engages the native valve annulus. With the upperinflow portion 74 expanded, the holder, or a portion thereof, (e.g., theextensions 110, 150, 170 and adaptor are removed over the cords 125,135, 145 as depicted in FIG. 21D) may be removed from the surgical zonewhile the loops 120, 130, 140 remain loosely around the frame so thatproper positioning of the prosthetic heart valve can be confirmed. Ifthe positioning is confirmed, the cords 125, 135, 145 may be cut and thecords (and loops) removed. If the prosthetic heart valve is determinedto be improperly positioned, the delivery tool and holder may beadvanced over the cords towards the prosthetic valve and the upperinflow region may be constricted by increasing tension on the cords torestrict the upper inflow portion, and the prosthetic valve may berepositioned as needed or desired.

A cord that forms a loop for retaining the prosthetic valve in aconstricted configuration may be made of any suitable material and mayengage the prosthetic valve in any suitable manner. In embodiments, thecords are formed from surgical suture material. The cords, among otherthings, can function to crimp the valve upper inflow cuff, hold thevalve firmly to the holder when tensioned, and/or maintain a tether withthe valve even after the holder or delivery system have been removedfrom the surgical cavity. A cord may be one long suture routed throughthe valve in one or more (e.g., three) instances; one or more (e.g.,three) sutures routed through the valve once each; or a combinationthereof. As a result of either condition, there are multiple (e.g., six)suture arms that exit the valve. In the case of three sutures, eachtether suture can encapsulate ⅓, ⅔, 360° or more of the valvecircumference. In such cases, all of the functions of the tether can beachieved with ⅓^(rd) circumferential encapsulation. Accordingly, it maybe desirable to limit each suture to ⅓r^(d) encapsulation as additionalencapsulation may lead to greater suture removal forces at the end ofthe procedure. High tether suture removal forces can lead to valvedislodgement. Accordingly, in some embodiments, small diameter sutureswith high strength may be preferred [(e.g., 3-0 ultra-high molecularweight polyethylene (UHMWPE)]. Of course other sutures (e.g., 2-0Polypropylene, 2-0 Nylon, 4-0 UHMWPE, or the like) or other suitablematerial may be used. The loops may be routed through the lower inflowcuff, central inflow cuff, the outflow rail & tabs, or combinationsthereof.

A version using two cords 125, 135 to surround a periphery of aprosthetic heart valve frame portion is shown in FIGS. 22A-B. The cordsmay be of different color (e.g., blue and red). The cords may beconfigured in an asymmetric gathering manner, such as a purse stringmanner (FIG. 22A), a symmetric gathering manner, such as a superiorpurse string manner (FIG. 22B), or any other suitable manner.

Regardless of the number of cords or suture style, the holder mayinclude one or more extensions forming one or more conduits for thecords. The conduits may run the length of the extension or through onlya portion of the extension. For example, as shown in the embodimentdepicted in FIGS. 20-21, a conduit may be formed at a distal end portionof an extension. The conduits may route one, two, or more arms of acord, depending on the style of the loop. In the embodiment depicted inFIGS. 20-21, each of the three extensions routes two arms of the cord toeach of the three lobes of the prosthetic valve. In the embodimentsdepicted in FIGS. 20-21, the three extensions (110, 150, 170) arepreferably seperated at 120° each.

In such embodiments, the extentionss preferably flare out enough toclear leaflets of the prosthetic valve upon holder removal orreinsertion from the valve, but not flare out so much that they snag onthe outflow rail. An illustration is provided in FIG. 23, where two armsof a first cord 125 in inserted through a distal conduit of a firstextension 110, two arms of a second cord 135 in inserted through adistal conduit of a second extension 150, and two arms of a third cord145 in inserted through a distal conduit of a third extension 170. Inthe embodiment depicted in FIG. 23, the extensions are separated at 120°and are inserted into valve in an orientation to avoid contact with thethree valve leaflets 33A, 33B, 33C. In the embodiment depicted in FIG.23, each of loops 120, 130, 140 of the cords extends about 120° aroundan upper inflow portion of frame 24 of the prosthetic valve. Inaddition, the depicted embodiments shown each of the cords extendingthrough a single lumen of adaptor 160.

Preferably holder extensions are sufficiently rigid to cumulativelysupport crimping loads of 25-30 lbs. Having the extensions take atubular shape or I-beam geometry helps to prevent deflection of theextensions. The holder may also function to provide a rigid connectionbetween the prosthetic valve device and the delivery system when theloops are tensioned, which allows for repositioning of the prostheticvalve by twisting or adjusting the vertical positioning of the deliverysystem. The legs could be metal, plastic, or any other material that isrigid or semi-rigid. An illustration of an I-beam holder extension 110is depicted in FIG. 24. I-beam geometry should better resist torsionalforces.

In order to adjust the positioning of the prosthetic valve via theholder, the holder is preferably rigidly attached to the delivery systemshaft. The connection with the holder to the shaft preferably resistsboth axial and torsional forces at the same time. One example of aholder-shaft connection is depicted in FIG. 25 in which snaps or indents168 of adaptor 160 of holder cooperate with detents 212 of shaft 210 ofdelivery system. The adaptor 160 and shaft 210 may include an autoaligning key 168 for rotational stability. Of course any other suitableholder-shaft connection may be employed, such as other snap fits withdetents, bayonets, threaded connections, ball bearing airline fitting,shoe horn connections requiring connection then 90° rotations, and thelike. Some examples of such connections are shown in FIGS. A9-A12 ofU.S. Patent Provisional Application No. 61/819,488, entitled SURGICALHEART VALVES AND ASSOCIATED APPARTUSES, SYSTEMS AND METHODS, filed onMay 3, 2013, which as indicated above is incorporated herein byreference to the extent that it does not conflict with the disclosurepresented herein.

Additional Description

Provided below is additional discussion of tripod holder and ratchetingdelivery system embodiments. Some embodiments presented below may thesame as or similar to those described above.

The embodiments of holders and delivery systems described in thissection, among other things, provide a solution to inaccurate placementand insufficient visibility with sutureless valve delivery systems.

Preferably, the prosthetic valve would come packaged with a holder. Thesurgeon would first size the native valve annulus and then choose theproper valve with holder. The holder/valve would then be removed fromtheir packaging and placed in an ice bath. The holder/valve would thenbe coupled or connected to the delivery system shaft. The valve wouldthen be crimped using either a disposible crimper or the built-insutures. The crimped valve would then be lowered into a patient to thelevel of the native valve annulus to be replaced and warm saline wouldbe sprayed on the valve. The prosthetic valve would be rotated so thetabs align with the native leaflet commissures and the ratchet on thehandle would be actuated in the deployment mode. Following prostheticvalve expansion, if the positioning were not right, the surgeon wouldswitch the ratchet to crimp mode and the valve would be crimped andrepositioned. After the repositioning is complete, the valve would beratcheted out again in deployment mode and the positioning would beconfirmed. To remove the holder from the prosthetic valve, a buttonwould be depressed on the handle to sever the sutures. The handle withholder would be removed from the patient. The three suture remnantswould then individually be plucked from the prosthetic valve to completethe implantation.

Inaccurate placement is accounted for by having a three pronged holderfixed to the valve by three removable sutures. The holder allows foreasy rotation and repositioning of the prosthetic valve in the nativevalve annulus through its rigid attachment at three locations. Theattachment locations could be on the upper inflow cuff on the outside ofthe leaflets and/or on the lower inflow cuff with the three prongs goingthrough the inner orifice of the leaflets. The three sutures affixed tothe prosthetic valve can be used to reduce the valve diameter throughpulling them tight with a ratcheting mechanism in the handle. Theprosthetic valve may be deployed by warming the valve and releasing thetension on the sutures (reverse ratcheting). If one wanted to controlboth the upper and lower inflow, an additional suture could be lassoedthrough the end of the inflow opposite the holder. By having threesutures crimp the valve at 120 degrees, uniform reduction of the valvehas been demonstrated. A cutting mechanism in the handle may be used tosever the sutures and allow for them to be pulled out after deployment.

Because this embodiment uses just three small tubes to attach to thevalve, visibility of the inflow cuff and anatomy is unencumbered by anybulky cones or other delivery tool components. Confirmation that theprosthetic valve is seated on the native valve annulus may be achievedby simply ratcheting the upper inflow of the prosthetic valve in untilthe native valve annulus is seen.

The handle mechanism may have a single pushbutton that actuates a gearwhich retracts the three sutures linearly. Achieving this linear travelcould be achieved by spooling a wire around the gear, using a worm-gearto translate the rotational to linear travel, or simply using linkagesto achieve the desired linear travel. The pushbutton could be in thesurgeon's dominant hand or could be attached to the handle by a tether,which could then be operated by the surgeon's non-dominant hand or anassistant. Alternative to a purely mechanical suture tighteningmechanism, a servo motor could be used to tighten and loosen thesutures. The advantage of using a motor is that the surgeon would havegreater stability while operating the tool (similar to the difference inperformance of using a hand cranked drill which requires two hands forstability vs a hand held power drill which can easily be operated withone hand). In any case, this embodiment assumes the valve crimpingmechanism can be both ratcheted in two directions, crimp and deploymentmodes. A prawl or pulley mechanism may be used to prevent backwardsmotion. Crimp and deployment modes could be achieved either through tworatchet buttons or through one button with a crimp/deployment switch.Alternatively, a threaded handle could be used.

The following are deployment steps that may be performed (post-sizing):(1) Rinse Valve; (2) Chill Valve; (3) Transfer Valve/Holder toDisposable Crimper; (4) Crimp Valve with Disposable Crimper; (5) AttachValve/Holder to Delivery Tool Shaft; (6) Actuate crimping ratchet totighten Holder; (7) Remove Valve from Crimper; (8) Remove Disk fromHolder; (9) Position Valve within Annulus; (10) Warm Valve w/ warmsaline; (11) Unratchet Valve into position; (12) Reratchet andreposition/redeploy as necessary; (13) Actuate Holder Removal Button tosever three gathering Sutures and unlock flexible rear Shaft; (14) Pullflexible rear Shaft from back of Delivery Tool to remove gatheringSutures; and (15) Remove Delivery Tool/Holder.

Other Embodiments

Versions of holders other than the tripod are contemplated, includingone that attaches to the outflow rail or tabs using many extensions andanother that cinches the outflow rail and tabs with a plastic sleeve orband. Examples are shown in FIGS. A16-A17 of U.S. Patent ProvisionalApplication No. 61/819,488, entitled SURGICAL HEART VALVES ANDASSOCIATED APPARTUSES, SYSTEMS AND METHODS, filed on May 3, 2013, whichas indicated above is incorporated herein by reference to the extentthat it does not conflict with the disclosure presented herein.

Implant Process

For purposes of example, a procedure will now be described forimplanting a prosthetic valve device, such as Medtronic, Inc.'s EnableII valve, that may be used employing a variety of embodiments of aholder and delivery system described herein. Following removal of thepatient's native leaflets and debridement of the native annulus, asurgeon typically sizes the native annulus and selects the properreplacement valve system. The replacement valve system with holder andcord are then removed from their packaging and placed in an ice bath.The holder/valve are then typically coupled or connected to a deliverysystem shaft. The prosthetic valve would then be crimped using either adisposable crimper or built in sutures. Alternatively, the prostheticvalve could be crimped prior to attachment to the delivery system. Thecrimped prosthetic valve would then be positioned within a patient andlowered to the level of the native valve annulus and warm saline wouldbe sprayed on the prosthetic valve. The upper inflow of the prostheticvalve would remain crimped due to circumferential loops that are undertension. The prosthetic valve would be rotated so the tabs align withthe native leaflet commissures and a delivery system actuation elementwould be actuated to release tension on the loops. The surgeon wouldthen slide the delivery system and holder out of the surgical cavity tocheck positioning of the prosthetic valve. If the positioning were notright, the surgeon would slide the delivery system back to theprosthetic valve, actuating an actuation element on the delivery system,and the prosthetic valve would be crimped via the tensioned loops andcould be repositioned. After the repositioning is complete, theprosthetic valve would be deployed again via the deployment system andthe positioning would be confirmed. To complete the prosthetic valvedeployment process, cords would be cut when the delivery system ispulled out of the surgical cavity. The suture remnants (typically three)would then individually be plucked from the prosthetic valve to completethe implantation.

If initial deployment of the prosthetic valve is above the native valveannulus, re-tensioning of loops around the upper inflow portion of theprosthetic valve frame will only reduce the upper inflow cuff andtherefore won't allow for the expanded lower inflow cuff to pass belowthe native valve annulus. Accordingly, one or more loops may bepositioned around the lower portion of the inflow cuff or the prostheticvalve may be removed from the surgical cavity and recrimped. To recrimpthe prosthetic valve, first the prosthetic valve may be warmed to returnit to its native shape if the frame, or components thereof, is formedfrom, for example, shape memory material such as Nitinol. Next theprosthetic valve may be chilled and a funnel, such as a clamshellfunnel, may be placed on the delivery system shaft proximal to theprosthetic valve. A guide may be used to guide the prosthetic valvethrough the funnel, crimping the entire prosthetic valve. The clamshellfunnel may be opened, the prosthetic valve may be removed from theprosthetic valve guide, and any residual cord slack may be collected byactuating an actuation element.

Delivery System Tether Engagement Methods

In some embodiments, a delivery system performs at least threefunctions. First, it is able to connect with the adaptor and cords of aholder. Second, it is able to crimp at least a portion of a prostheticvalve, such as the upper inflow cuff of the prosthetic valve, bytensioning the cord in an axial direction. Third, it is able to releaseall, or substantially all, tension on the cord allowing for the portionof the prosthetic valve to expand and for the holder to slide back fromthe valve.

A cord may be connected to a delivery tool tensioning mechanism in anysuitable manner, and a delivery tool may have any suitable tensioningmechanism. An example of a connection and tensioning mechanism is a cordcomprising a wire, which can be wrapped around a coiling wheel. Thecoiling wheel could be positioned parallel with the center plane of thetool or at any other orientation with the center line of the tool. Thecoiling wheel could have magnets in it that allow for easy connection ofa metal tether coupling to the wheel for the initial setup. In anotherembodiment, the cord may be pulled directly through a hole in thecoiling wheel and after a few wheel revolutions the cord is firmlyattached to the wheel.

Embodiments of a delivery tool 200 comprising a coiling wheel as atensioning mechanism are shown in FIGS. 26-27. As depicted in FIG. 26, adelivery tool 200 has a shaft 210 connected to an adapter of a holder160. One or more cords (not shown in FIG. 26) extend through one or moreconduits of shaft 210 and connect to tensioning mechanism housed withinhandle 220. The handle includes actuation mechanisms 230A, 230B, in thiscase as crank 230A and tension release button 230B. The crank 230A maybe turned to increase or decrease tension on the cord. The tensionrelease button 230B may be depressed to release all or substantially allof the tension on the cord.

FIG. 27 shows an embodiment of the tensioning mechanism of the deliverytool 200 depicted in FIG. 26. As shown, the shaft 210 has a lumen 215that forms a conduit for cord 125, which is coupled to tensioning wheel410. The tensioning wheel 410 may be rotated about shaft 412 to adjusttension on cord 125.

One example of a method that may be used for implanting a prostheticvalve with a delivery tool and holder, where the deliver tool has atensioning mechanism and release mechanism (e.g., the embodimentdepicted in FIG. 26), includes (1) snare and pull a cord to the deliverytool tensioning mechanism; (2) connect cord to tensioning mechanism; (3)actuate tensioning mechanism to constrict or crimp prosthetic valve; (4)crimp prosthetic valve with crimping device if needed or desired; (5)position prosthetic valve within surgical cavity of patient; (6) warmvalve; (7) press release button of tensioning mechanism to allowexpansion of prosthetic valve; (8) actuate tensioning mechanism tore-cinch/reposition prosthetic valve, if necessary; (9) pull tool/holderout of surgical cavity of patient while holding release button oftensioning mechanism; (10) confirm correct implant position ofprosthetic valve; (11) cut cord and remove from around prosthetic valve.

In some embodiments, the cord comprises a rack, beaded chain, beltand/or 3D pulley and the tensioning mechanism comprises a spur gearsprocket, screw and/or worm gear that engages with the cord. Forexample, FIG. 28 illustrates a cord 125 having a beaded chain and asprocket 510 configured to engage the beaded chain. Rotation of thesprocket 510 can increase or decrease tension on the cord 125.

One way of advancing a belt with minimal components would be to use anindexing binding mechanism. One could use binding slotted componentsthat grip when traveling in the proximal direction and are loose whentraveling in the distal direction. This could be achieved by changingthe angle from perpendicular with the belt in the non-grip direction andat a slight angle in the grip direction.

In addition to, or as an alternative to, using simple belts or flexibleracks, unique geometries could be used such as a belt with a roughsurface or a chain belt.

Examples of mechanisms for coupling cord to tension mechanism and forcontrolling tension mechanism are depicted in, and discussed with regardto, FIGS. A19-A40 of U.S. Patent Provisional Application No. 61/819,488,entitled SURGICAL HEART VALVES AND ASSOCIATED APPARTUSES, SYSTEMS ANDMETHODS, filed on May 3, 2013, which as indicated above is incorporatedherein by reference to the extent that it does not conflict with thedisclosure presented herein.

A tether adapter may form a part of a cord so that the cord may matewith a tensioning mechanism. The distal portion of the cord (e.g., asuture) may be potted into the adapter. Of course any other suitablemechanism, such as tying, adhesive, crimping, or the like, may be usedto couple a distal portion of a cord with an adapter configured to matewith a tensioning mechanism. The adapter may have any suitable featureto mate with a tensioning mechanism such as a rack, beaded chain, belt,3D pulley and/or the like. If cords are to be dependently controlled,such cords may together be coupled to a given tether adapter.

An example of a delivery tool having a sprocket tension mechanism isshown in FIG. 29. In the depicted embodiment, the sprocket 510 engages abeaded chain of cord 125. The sprocket 510 is coupled to a spur gear 530that engages gear 520. Rotational movement of actuation element 230 (inthis case a rotatable knob) rotates gear 520, which causes spur gear 530and sprocket 510 to rotate, thereby adjusting tension on cord 125.

One or more actuation elements may be placed at any suitable location ofthe handle of a delivery device. As shown in FIG. 26, actuation elementsmay be placed on a side (e.g., top, bottom, or side) of the handle. Asshown in FIG. 29, an actuation element may be placed at the back of thehandle. In some embodiments, the actuation mechanism is a button,switch, knob, lever, and/or the like, coupled to a motor and suitablecontrol electronics. Accordingly, the tethering mechanism may be poweredby a motor rather than manually actuating (e.g., ratcheting, turning,cranking, etc.) the mechanism.

An example of the tether tensioning function being accomplished with anelectromechanical delivery system is shown in FIG. 30. In the housing ofthe handle of the delivery tool are disposed a motor 610, such as alinear servo motor or rotary motor with, for example, a spur rackinterface, a power supply 630, control electronics 620, such as acircuit board, and appropriate connections to actuation elements 230,270 disposed on handle. The power supply 630, control electronics 620,and motor 610 are operably coupled. The actuation elements 230, 270 maybe actuated to control tension on a cord. By way of example, the frontportion 232 of actuation element 230 may be depressed to increasetension, and the back portion 234 of element 230 may be depressed todecrease tension. A tension release button 700 may also be included.

Other mechanism or actuation elements that may be employed with powereddelivery systems are shown in FIGS. A42-A47 of U.S. Patent ProvisionalApplication No. 61/819,488, entitled SURGICAL HEART VALVES ANDASSOCIATED APPARTUSES, SYSTEMS AND METHODS, filed on May 3, 2013, whichas indicated above is incorporated herein by reference to the extentthat it does not conflict with the disclosure presented herein.

Remote Unit to Control Tension

In some embodiments, one or more actuation elements for controllingtension on one or more cords may be located away from the handle of thedelivery tool. Such embodiments allow for the use of one hand toposition the prosthetic valve and another to control constriction orexpansion via tension on one or more cords or allow for two people toperform different aspects.

If the tension mechanism is powered, the tensioning mechanism may bedisposed in the handle and the actuation mechanism may be a distancefrom the handle electrically or remotely coupled to the tensioningmechanism in the handle.

Examples of delivery systems with actuation elements away from a handleof a delivery tool are shown in FIGS. 31-32. In the embodiments depictedin FIG. 31, the handle 220 includes an actuation element 230 and remoteunit 260 includes another actuation element 240 coupled to the handle220 via flexible shaft 250. This allows a user (or two users) to employone hand (or one user) to position the prosthetic valve via handle 220and actuate element 230 and to use another hand (or another user) toactuate element 240 on remote unit. Actuation elements 230, 240 may beused to control tension of the same or different cords. If used tocontrol the same cord, a user may choose which hand (or which user) touse. In some embodiments, actuation element 230 is a tension releaseactuation element and actuation element 240 is a tension controlelement.

In the embodiment depicted in FIG. 32, handle 220 does not includeactuation elements, while remote unit 260 that is coupled to handle 220via flexible shaft 250 includes one or more actuation elements (onlyone, 230, depicted).

Other embodiments are depicted in, and discussed with regard to, FIGS.A42-A43 of U.S. Patent Provisional Application No. 61/819,488, entitledSURGICAL HEART VALVES AND ASSOCIATED APPARTUSES, SYSTEMS AND METHODS,filed on May 3, 2013, which as indicated above is incorporated herein byreference to the extent that it does not conflict with the disclosurepresented herein.

Adjustable Shaft Concept

Some surgeons may have different preferences on the shaft length of thehandle depending on any given patient. Accordingly a shaft of a deliverytool described herein may have any suitable length or may be adjustable.Embodiments of adjustable length shafts using, for example a lock/unlockswitch, are depicted in and discussed with regard to FIG. A51 of U.S.Patent Provisional Application No. 61/819,488, entitled SURGICAL HEARTVALVES AND ASSOCIATED APPARTUSES, SYSTEMS AND METHODS, filed on May 3,2013, which as indicated above is incorporated herein by reference tothe extent that it does not conflict with the disclosure presentedherein.

Cord Cutting Mechanisms

One way to cut a cord after the prosthetic valve is properly implantedis to have the user take scissors to cut the cord. Another way is tohave the cords automatically cut. This could occur in the deliverysystem handle, in the shaft, within the holder, etc. Some of the ideascontemplated herein include rotation of a sharp disk, the axial travelof sharp edges, or simply having a raised cut-point on the holder as isdone on many surgical valves. In one version, one end of the cord (inembodiments where two arms are fed through a holder, shaft or deliverysystem) would remain fixed to the holder shaft, or delivery system, etc.allowing for the cords to be pulled out with the delivery system handle.A second contemplation would leave the cords about the valve after thedelivery system has been removed, allowing for each of the cords to bepulled out individually. A third contemplation would have each of thecords automatically pulled from the valve incrementally by the deliverysystem.

Examples of cutting apparatuses incorporated into a delivery tool areshown in FIGS. A13-A14 and A48-A50 of U.S. Patent ProvisionalApplication No. 61/819,488, entitled SURGICAL HEART VALVES ANDASSOCIATED APPARTUSES, SYSTEMS AND METHODS, filed on May 3, 2013, whichas indicated above is incorporated herein by reference to the extentthat it does not conflict with the disclosure presented herein. Anexample of a raised cut point for manual cutting or a cord is shown inFIG. A15 U.S. Patent Provisional Application No. 61/819,488.

In some embodiments, the cords are severed in the handle and the handleis disconnectable from the shaft. After the cord cutting element isactuated, the handle is disconnected from the shaft. The shaft may beheld such that the holder remains in position (e.g., at the level of theupper inflow cuff) and the sutures may be pulled out one at a time.Because the sutures are being pulled radially from the prosthetic valve(due to holder being in place), not vertically, there is little or norisk of valve dislodgement from pulling the sutures from the valve.

In some embodiments, automatic cord removal occurs when the deliverytool handle is retracted. In such embodiments, it is desirable tomaintain the holder in position relative to the prosthetic valve.Because the holder is at the level of the loops (e.g., valve inflowcuff), the forces are all radial and there is little to no risk of valvedislodgement from this process.

Embodiments with Offset Holder

The discussion provided in this section is generally directed to holderswith extensions offset from the longitudinal axis of a prosthetic valve.However, it will be understood that some of the discussion presented inthis section may be applicable to any holder or delivery systemdescribed herein (e.g., the discussion below regarding crimp limiters,quick connects, handle and actuation element configurations, implantprocedure, etc.).

In some embodiments, a holder and shaft of delivery device is offsetfrom a longitudinal axis of a prosthetic valve to improve thephysician's view during implant. One such embodiment is depicted in FIG.33. As depicted, the holder 100 includes two extensions 110, 150 (butmany contain any suitable number of extensions) and an adaptor 160 toretain relative positions of extensions and to manage cords (e.g., asdiscussed above with FIGS. 1-9). The adaptor 160 is configured toconnect to shaft 210 of a delivery tool such that the shaft and holderare offset and generally parallel to the longitudinal axis of theprosthetic valve 20. In the depicted embodiment, extension 110 extendson the exterior of the valve 20 (i.e., not within a central opening ofself-expanding frame 24) while extension 150 extends within a centralopening of self-expanding frame 24.

In the embodiment depicted in FIG. 33, the prosthetic valve has an upperinflow region 4 at the top of the skirt, a lower inflow region 6 at thebottom of the skirt, and a skirt waist 5, as well as an upper outflowregion 1, a middle outflow region 2, and a lower outflow region 3. Whendiscussing a holder or delivery device in this section, a prostheticvalve as depicted in FIG. 33 will often be described. However, it willbe understood that the holder and delivery systems described in thissection may be used to deliver prosthetic valves with otherconfigurations.

Still referring to FIG. 33, the holder 100 has three loops 120, 130,140, with one loop being disposed about the upper inflow region 4 of theprosthetic valve 20, another being disposed about the lower inflowregion 6, and the other being disposed about the middle 2 to upper 1inflow region.

As shown in FIG. 33, a valve apparatus may include a skirt having anupper edge, a lower edge and a waist. The skirt may include a marking 7to facilitate alignment with the patient's annulus, one or more markings8 for alignment with commissures, or both markings 7, 8. Additionalinformation regarding markings is described in U.S. Provisional PatentApplication No. 61/819,486, entitled SURGICAL HEART VALVES ANDASSOCIATED APPARTUSES, SYSTEMS AND METHODS, filed on May 3, 2013, U.S.Provisional Patent Application No. 61/930,851, entitled SURGICAL HEARTVALVES AND ASSOCIATED APPARTUSES, SYSTEMS AND METHODS, filed on Jan. 23,2014 and in U.S. patent application Ser. No. ______, entitled MEDICALDEVICES FOR IMPLANTING IN A VALVE AND ASSOCIATED METHODS, filed on thesame day as the present nonprovisional application, and having attorneydocket no. C00007020.USUS, which patent applications are herebyincorporated herein by reference to the extent that they do not conflictwith the present disclosure.

Referring now to FIG. 34A, a schematic drawing of an embodiment of aholder depicted in FIG. 33 is shown without the captured prostheticvalve device 20. From an opening 112 in one extension 110 a loop 130exits. From a first opening 154 of the other extension 150 a loop 110exits, and from a second opening 152 of the extension 150 another loop140 exits. A portion of the cords that form the loops 120, 130, 140extend through conduits in the extensions 110, 150 and through adaptor160. The extensions and adaptor may have any suitable number ofconduits.

Referring now to FIG. 34B, an embodiment of a longitudinal section ofthe holder depicted in FIG. 34A is shown. In the depicted embodiment,the first extension 110 has a conduit 115 extending the length of theextension, the second extension 150 has a conduit 155 extending thelength of the extension, and the adaptor 160 has a conduit 165 extendingthe length of the adaptor. The conduit 165 of the adaptor is incommunication with the conduit 115 of the first extension and theconduit 155 of the second extension. A portion of the cord 125 forming aloop (not depicted in FIG. 34B) extends through the conduit 115 of thefirst extension and the conduit 165 of the adaptor; and portions of thecords 125, 145 forming loops (not depicted in FIG. 34B) extend throughthe conduit 155 of the second extension and the conduit 165 of theadaptor. While one conduit is depicted for each of the first extension,the second extension and the adaptor, it will be understood that aholder and its components may have any suitable number of conduits formanaging the cords. End portions of the cords that extend beyond theadaptor (and delivery system shaft) may be operably coupled to one ormore tensioning apparatus and actuation elements for controlling thetensioning apparatus (e.g., as discussed above). The loops may becontrolled individually or as a group of two or more.

While the holder depicted in FIGS. 34A-B includes two extensions, itwill be understood that a suitable holder may comprise any othersuitable number of extensions. For example, if three loops are employed,the holder may reasonably have one, two or three extensions.

The holder, loops or handle may be configured to restrict or limit theamount that any one or more loops may be constricted to limit crimpingof the valve apparatus, thereby preventing the valve from being overcrimped. Any suitable crimp limiter may be employed. In embodiments,crimp limiting may be accomplished by assembling a bead to one of theloop lines and assembling a crimp sleeve behind the bead, which thenlimits the amount of travel that the loops can travel. Limiters may beplaced on any one or more loop lines. Preferably, a limiter is placed ona loop that is configured to retain a valve apparatus in an outflowregion, such as the upper skirt/lower outflow region.

In some embodiments, two or more loops may be actuated by the samemechanism. In such embodiments, a travel stop for one of the loops caneffectively limit crimping of all of the loops controlled by the samemechanism.

In some embodiment, a crimp limiter is not employed for a loop at alower inflow region. The lower inflow region presents less concernregarding damaging the valve or frame. Of course, a crimp limiter may beemployed for a loop in this region.

A crimp limiter (e.g., travel stop described above) preferably can bemanufactured in a consistent manner. For the embodiment described above,the travel stop relies on precise knot tying and loop line lengths toget low variability in crimp stop locations. To facilitate a lowvariability assembly process, manufacturing fixturing may be employed toan effective design. In embodiments, fixturing can involve posts to holda valve apparatus in place and posts to set the suture length where theknots/crimp sleeves belong. By using crimp sleeves, the travel stops maybe reproducibly placed. Crimp sleeves alone may not be strong enough forthe forces seen with cinching the valve, so knots can be placed directlybehind or in front of the crimp sleeve that prevent slipping of thetravel stops.

An overview of an embodiment of a manufacturing process for operablycoupling a holder to a valve apparatus includes assembling loops tocommissures of a frame of a valve apparatus at three levels. Next a beadis assembled to one arm of a loop configured to retain the valveapparatus in the upper skirt region. Next the holder is assembled ontothe three cinch loops. Next a crimp sleeve or quick connect component isadded and excess loop material length is trimmed

In embodiments, one or more loops are coupled to the valve apparatus(e.g., to the frame) to prevent the loops from slipping off of the valveapparatus. In embodiments, the loops are coupled via the commissures. Inembodiments, the loops are coupled via sutures. Of course, the loops maybe coupled in any suitable location and in any suitable manner. Forexample, the frame could have a curled pig tail that constrains theloop, the frame could flare outwards to prevent the suture from slidingoff, etc.

Referring now to FIG. 35, an embodiment of a holder 100 havingdisc-shaped crimp limiting elements 196, 198 is shown. The holder 100 ispositioned such that one extension 110 or leg is outside of prostheticvalve 20 and one extension 150 is positioned within a central opening ofvalve 20. The disc crimp limiters 196, 198 are formed as a part of, orare attached to, extension 150 configured to be positioned within theprosthetic valve 20. Crimp limiting elements 196, 198 limit the amountthat a frame of device 20 can be crimped, because the frame will engagethe limiting elements 196, 198 and constrict no further, even if furthertension is applied to loops 120, 130, 140. In the embodiment depicted inFIG. 35, loops 120 and 140 may be controlled together. Accordingly,crimp limiting element 196 can serve to prevent further crimping by bothloops 120, 140 because stopping further crimping of one loop will stopfurther crimping of the other loop if the loops are dependentlycontrolled. Crimp limiting element 198 can serve to limit crimping byindependently controlled loop 130 positioned around the inflow region ofthe valve 20.

A holder may include any suitable number of crimp limiting disc-shapedelements. In some embodiments, a holder includes one disc-shaped crimplimiting element for each loop or group of loops that surrounds aportion of a valve. In some embodiments, a holder includes onedisc-shaped crimp limiting element for each loop or set of loops thatare independently controllable. In some embodiments, a disc-shaped crimplimiter is a cylinder. A cylinder can effectively limit crimping of aplurality of independently controllable loops.

Referring now to FIGS. 36A-B, a prototype of an embodiment of a holderdepicted in FIG. 35 is shown positioned within an embodiment of a valve.The schematic drawings in FIGS. 36A-B are bottom-up views, showing crimplimiting element 198, loop 130 and lower inflow region 6 of prostheticvalve. FIG. 36A shows the valve in an expanded configuration. FIG. 36Bshows the valve in a constricted configuration, where crimping islimited by crimp limiting element 198.

In embodiments, where the holder is a side mounted holder (e.g., theembodiments described above in this section), a seam is preferably at acommissure location where the holder is or will be attached tofacilitate uniform crimping.

In embodiments, the valve apparatus is configured to flare at the skirtat the lower inflow region. When the valve is implanted using a tool asdescribed herein, the skirt may be allowed to flare at the lower inflowregion while the outflow and upper inflow remain crimped (e.g., throughthe use of more than one loop—e.g., loops 110 and 140 as describedabove). FIG. 37 presents a schematic drawing of a flared skirt at thelower outflow region 6 and crimped upper inflow 4 and outflow 1, 2, 3regions. The skirt waist is properly aligned with the annulus 14 of thenative valve in the drawing shown in FIG. 37.

Preferably, a delivery tool described herein allows for rapid connectionof a handle to the apparatus for controlling the diameter of the loops.With embodiments of systems as described herein, the loading process cantake seconds as opposed to minutes with previously available systems.

To facilitate rapid loading, a quick connect system may be employed. Inembodiments, quick connection can be achieved by having two cords orsets of cords on the valve, one for the outflow and one for the inflow,which quickly connect with the delivery handle actuators via arms thatengage a bead. By allowing the surgeon to quickly disconnect andreconnect, they may set the tool aside during positioning confirmation,and reconnect if necessary to reposition the valve.

An example is depicted in FIG. 38, where a first cord 129 includes afirst quick connect mechanism, such as the ball 128 depicted; and secondcord 135 includes a first quick connect mechanism, such as the ball 138depicted. One or both of the first and second cords may include morethan one cord. For example, cord 129 may include cord 125 and cord 145as depicted in FIG. 34B, because in some embodiments constriction andexpansion of loops of such cords may be dependently controlled.

Referring now to FIGS. 39A-B, handles 220 of a delivery system havingquick connect mechanism configured to cooperate with quick connecttether adapters (e.g., as shown in and discussed above with regard toFIG. 38) are shown. In FIG. 39A, a schematic drawing is shown. In FIG.39B, schematic drawing of a prototype is shown. As depicted, the handle220 includes channels or conduits through which one or more cords 129,135 may run. Handle includes swinging arms 290A, 290B that areconfigured to capture or release tether adapters of cords 129, 135. Thearms 290A, 290B include curved ends 295A, 295B with slots for receivingthe cords. The width of slots sufficient large to receive a portion ofthe cord distal to a capture feature (e.g., balls 128, 138 depicted inFIG. 38) but less than the width or diameter of the capture feature. Forexample, the capture feature (e.g. bead or ball) may be snagged byswinging arms. When unactuated a plunger (or other suitable element) maypush the capture feature (e.g., bead or ball) out of the actuator arms.

Referring now to FIGS. 40-41, a delivery system having quick connectelements is depicted. The system includes a holder 100 (e.g., any holderas described above), a shaft 210 through which cords may run, and ahandle 220. The handle includes two actuation elements 230, 240, in thiscase triggers, and a recess for receiving a actuation elements 232, 242.Actuation elements 232, 242 are coupled to cords that control loops thatcontrol constriction and expansion of prosthetic valve 20. Actuationelements 232, 242 can include gears coupled to tether elements of thecords. Handle 220 can include cooperating gears that are operablycoupled to actuation elements 230, 240. When actuation elements 232, 242are received by recess 222 of handle, gears within the handle can engagegears within actuation elements 232, 242 such that triggers 230, 240 maybe actuated to increase or decrease tension on the cords to controlconstriction or expansion of prosthetic valve 20.

As shown in FIGS. 40A-C, handle may include rod 218 to facilitate propercoupling of handle 220 with actuation elements 232, 242. Rod 218 ofhandle 220 may be inserted into a lumen of shaft 210 to align handle 220relative to shaft 210. Shaft 210 may be advanced over rod 218 untilactuation elements 232, 242 are properly received into recess 222 ofhandle 220.

Referring now to FIG. 41, a schematic view is shown of a portion of anembodiment of a shaft 210 that may be used with a system depicted inFIGS. 40A-C. Shaft 210 includes lumens 212, 214 through which cords mayrun. Each lumen 212, 214 may receive one or more cords. In someembodiments, lumen 212 receives one cord which is coupled to a firstactuation element on shaft, and lumen 214 received two cords with areboth coupled to a second actuation element on shaft. Shaft 210 alsoincludes lumen 216 configured to receive rod of handle.

A handle may take any suitable form and have any suitable actuationelement to control the diameter of a loop. For example, the handle maybe in one of the following form factors: pistol, bike break, pen style(with appropriate motor), transcatheter delivery system (rotary knobs),syringe, thumb wheel, or the like. Examples of such handles andactuation elements are depicted in, and discussed with regard to FIGS.11-20 of U.S. Provisional Patent Application No. 61/930,905, entitledVALVE DELIVERY TOOL, filed on Jan. 23, 2014, which as indicated above isincorporated herein by reference to the extent that it does not conflictwith the present disclosure.

For example and with reference to FIG. 42, a handle 220 havingtrigger-like actuation mechanisms 230, 240 is shown. In the depictedembodiments, the handle 220 includes locking elements 238, 248. Lockingelements 238, 248 are configured to lock trigger 230, 240 position.Locking elements 238, 248 are releasable one way locking elements. Astriggers 238, 248 are squeezed, locking elements 238, 248 lock triggerat predefined intervals (e.g., at intervals defined by teeth). Suchlocking mechanisms may be advantageous when manual actuation elements230, 240 are employed (as opposed to motorized elements), otherwisehuman force may need to be maintained on triggers to retain a prostheticvalve in a crimped position. Maintenance of force for extended periodsof time (e.g., several seconds or more) can be difficult, particularlywhile the prosthetic valve is being positioned. Such locking mechanismsmay also be advantageous when a medical assistant crimps the prostheticvalve and retains a crimped configuration of the valve with a deliverysystem, and then hands the delivery system to a surgeon for implanting.It will be understood that the locking mechanisms depicted in FIG. 42are shown for purposes of example and that other suitable lockingmechanisms are contemplated herein.

In some embodiments, a delivery system includes a crimp lockoutmechanism to prevent an excessive number of crimping and uncrampingevents. Typically, prosthetic valves can be crimped only a few times(e.g., three times) before their use is no longer advised. Any suitablecrimp lockout mechanism can be used. For example, if actuationmechanisms of the delivery system is motorized and the delivery systemincludes control electronics, the number of crimping and uncrampingevents may be counted electronically until a maximum number or crimpingand uncramping events is reached. Further crimping may be prevented tocause a new prosthetic valve to be used. If the actuation mechanisms aremanual, the crimp lock out mechanism may be, for example, a geared dialwith a peg that advances a set number of times before the peg advancesto a position that prevents further crimping. Of course, any othersuitable lockout mechanism may be employed.

An overview of an embodiment of a method of implanting a surgicalreplacement valve apparatus using an embodiment of a delivery tooldescribed herein presented below. The holder includes one or more loopsto control the extent which the valve frame is expanded or collapsed. Ina first step, a handle is operably coupled to the holder such that thehandle may be used by a surgeon to control the extent to which the loopscontract or allow expansion of the frame. Next, the valve is collapsed(i.e., crimped) by reducing the diameter of the one or more loops bymanipulation of one or more actuation elements on the handle. Next, thevalve is positioned in the crimped state. Next, the lower skirt isallowed to expand by increasing the diameter of a loop previouslyconstricting the skirt by manipulation of an actuation element on thehandle. Next, the outflow portion of the frame is expanded by increasingthe diameter of one or more loops previously constricting the outflowportion of the frame by manipulating one or more actuation elements ofthe handle. Next, the handle may be removed and the position of thevalve verified. If the position is determined to be improper, the handlemay be recoupled to the holder and the valve may be repositioned.Preferably, the valve is not crimped and released more than two or threetimes before proper positioning is achieved. If positioning isdetermined to be proper, the loops or an extension thereof may be cutand removed. In embodiments, the loops may be formed of suture wire orthread. Of course, any other suitable biocompatible material may beemployed.

Sheath Delivery System

Embodiments of delivery systems described in this section may reduce thevalve to a diameter no greater than 14 mm. The valve is connected to thedelivery tool via a threaded holder; however, a snap fit and/or othermechanisms are also contemplated. A clamshell funnel is then assembledonto the end of the delivery tool's sheath, and the sheath is advancedover the prosthetic valve (valve is stationary). This is achieved via athumb wheel on a rack. Various gear ratios and orientations of suchwheels/knobs have been prototyped. Prior to pulling the skirt into thesheath, the sheath may be spun to align the sheath commissure markerswith the valve skirt's commissure markers. After the valve is fullysheathed, the funnel is pulled off of the delivery tool. The valve maybe chilled prior to loading, however depending on the valve it may notnecessary.

The valve may then be heated via syringe or luer port on the handle, andthe prosthetic valve is placed within the surgical cavity of the patientand lowered to a level just below the native valve annulus using thedelivery tool. The user then retracks the sheath via the thumb wheelinterface, and allows the skirt to expand into a flared geometry. Theuser then observes the commissure markings and waist markings, andclocks the commissure markings with the native commissures and pulls thevalve up against the native valve annulus, such that the waist markingcorrelates closely to the native valve annulus. The user then fullydeploys the prosthetic valve and confirms positioning.

If the user is not satisfied with the positioning, they may advance thesheath over the valve to reposition it. While the inflow skirt may notbe able to be pulled into the sheath, enough reduction may be derivedfrom the crimping of the rest of the valve to allow the valve to berepositioned.

After the user is satisfied with the positioning, they cut the sutures,for example at a single cutpoint on the valve holder, and remove thedelivery tool & holder from the surgical cavity. By using flexiblesutures between the holder and the valve, the user may easily move thedelivery tool out of the way while confirming valve positioning.Additionally, a user can tug on the valve without dislodging it toconfirm sufficient engagement force. Because the sutures are looselysecured to the valve, a single rigid leg is necessary to push the valveout of the sheath during deployment. If the rigid leg were not present,the valve may only advance after the slack of the suture was removed andthen the valve may uncontrollably shoot out of the sheath after thetension between the skirt and the sheath is reduced.

Sheath delivery tool embodiments are depicted in and discussed withregard to FIGS. A72-A78 of U.S. Patent Provisional Application No.61/819,488, entitled SURGICAL HEART VALVES AND ASSOCIATED APPARTUSES,SYSTEMS AND METHODS, filed on May 3, 2013, which as indicated above isincorporated herein by reference to the extent that it does not conflictwith the disclosure presented herein.

A motorized sheath delivery system is depicted in and described withregard to FIGS. B1-B4 of U.S. Patent Provisional Application No.61/819,490, entitled SURGICAL HEART VALVES AND ASSOCIATED APPARTUSES,SYSTEMS AND METHODS, filed on May 3, 2013, which as indicated above isincorporated herein by reference to the extent that it does not conflictwith the disclosure presented herein. As indicated in the previouslyfiled provisional patent application, surgeons have indicated apreference for a handle configuration that encompasses a pen like gripand that requires minimal force in deploying sutureless prostheticvalves. Preferably, this force is imparted from either their thumb orindex finger. Due to the large forces involved in crimping a superelastic prosthetic valve, it can be difficult to maintain control duringprosthetic valve deployment when the surgical instrument is purelymechanical. To overcome this challenge, an electronic handle has beendeveloped that allows for the user to use a pen-like grip whileimparting very little force with their fingers, allowing for maximalcontrol of prosthetic valve deployment.

Several types of motors may be used to control deployment of asutureless valve. Both stepper and servo motors may be used. However,the lack of sufficient torque achievable in a small motor may result.Therefore, a DC motor combined with a high gear ratio may be used toachieve a sufficient torque to control deployment of a suturelessprosthetic valve.

An advantage to a DC motor is that a circuit board is not necessary tocontrol the DC motor. For example, an H-bridge circuit may be simulatedusing two push buttons. However, this may present difficulties withregard to controlling the speed of the motor. The speed would always bethe maximum allowed by the chosen battery/motor. It is preferred thatthe user be able to control the speed with which the valve deploys or isrecaptured. In some embodiments there are two push buttons, one forforward and one for reverse. If this configuration were used, the motormay go forward at a slow speed for a few seconds, but when the button isheld for longer periods of time the speed may ramp up to maximum speed.This would allow the user to rapidly get the sheath back, as would bedesired after the inflow of the valve has been deployed. Another buttonconfiguration would involve a rocker switch with a potentiometer, wherethe further forward the switch is rocked, the greater the speed. If theswitch were rocked only slightly forward, there would be a very slowvelocity of deployment.

For turning the device on, the device could have an on/off switch, or acircuit board that has a “shake-awake” feature.

The delivery handle may have a motor interfacing with a rack via apinion; however, other versions could also be used, such as a worm witha worm-rack, allowing the motor and rack to be parallel. Additionally,the motor could spool a cable or suture.

Another feature that can be added is a light source, such as an LEDlight, in the delivery tool shaft or sheath. This would allowillumination of the surgical cavity, providing the surgeon with bettervisibility of the valve while confirming valve deployment position. TheLED could be placed entirely within the sheath, on the outside of thesheath, or partially in and out of the sheath. Multiple LEDs could beused to provide additional illumination. Preferably, the light wouldturn on when the user moves the handle or depresses the deploymentbutton and remain on for a set period of time, such as 10 seconds.

IV. Accessory Devices to Facilitate Implanting Prosthetic Heart Valves

Crimping

An objective of the initial crimp of the valve is to reduce the valve inits entirety to a diameter small enough to easily translate down to thenative valve such as an aortic valve and still allow user visibility.This critical crimp diameter is typically 4 mm smaller than the nativevalve annulus size. So for a 19 mm valve, the valve should be crimped tominimally to about 15 mm. If the valve has components formed of Nitinol,the valve should be chilled prior to crimping so the valve can retainthe reduced diametric geometry. The crimping of the valve could occurwhile the valve is either attached or detached from the delivery system.If the valve is attached to the delivery system, a guide may not benecessary to push the valve through a crimping funnel, for example, asthe funnel could simply be pulled over the prosthetic valve; however,the guide serves the purpose of keeping crimping uniform.

Embodiments of crimping guides 800 and crimping funnels 900 are depictedin FIGS. 43-46. Referring now to FIG. 36 a crimping guide 800 has threearms (only two 810 820 are shown) 120° apart, which ensures the tabs ofthe valve are 120° apart during crimping. Extensions 812, 822 of armsform slots for receiving commissure posts of a prosthetic valve. Thearms also include shoulders 814, 824 that are configured to abut withlower inflow portion of the prosthetic valve to retain prosthetic valveat a reproducible depth in the guide 800.

FIGS. 344A-B show a hinged funnel 900 being slid over guide 800 andprosthetic valve 20 to crimp the valve 20.

FIG. 45 shows an opened hinged funnel 900 containing guide 800 andcrimped prosthetic valve 20.

FIG. 46 illustrates an embodiment of a hinged funnel 900 that includeschannels 910, 920, 930 for receiving arms of a crimping guide to ensureuniform and reproducible crimping results.

A similar crimping apparatus is shown in, and discussed with regard to,FIG. A93 of U.S. Provisional Patent Application No. 61/819,488, entitledSURGICAL HEART VALVES AND ASSOCIATED APPARTUSES, SYSTEMS AND METHODS,filed on May 3, 2013, which as indicated above is incorporated herein byreference to the extent that it does not conflict with the disclosurepresented herein, is an alternative crimper contemplated herein.

An embodiment of a process for crimping is now described. The methodincludes the steps that follow. Of course other steps, variations, oromissions are contemplated. Drawings are shown, as indicated, toillustrate some of the steps. FIGS. A82-A92 of U.S. Provisional PatentApplication No. 61/819,488 illustrate some of the steps of the methoddescribed below.

1) Rinse valve in separate sterile saline baths 3× (30 seconds each);2) Chill valve in approx. 5° C. sterile saline ice bath (30 seconds);3) Collect gathering suture with snare and pull gather suture throughthe rear of the delivery system handle;4) Place valve in the conical reducer, aligning valve tabs with thereducer slots;5) Place valve driver in the conical reducer, aligning the three driverprongs with the reducer slots;6) Collect excess gathering suture (In embodiments, it may be importantto NOT pull the valve into the conical reducer with the gather suture);7) Advance valve until valve driver has advanced fully;8) Collect excess gathering suture and press lock button on deliverysystem handle;9) Remove valve driver from conical reducer;10) Open the conical reducer's door and remove the delivery system withvalve in the delivery system cone;11) Manually seat the valve in the delivery system cone; and12) Press the unlock button on the delivery system handle and collectexcess gathering suture, and press the lock button on the deliverysystem handle when complete.

An embodiment of a process for re-crimping is now described. Recrimpingprosthetic valve fully may be performed on the valve if the valve hasnot been deployed into the patient. If the valve has been deployed inthe patient, recrimping fully is preferably not performed and the valvemay be discarded. The method includes the following steps (Of courseother steps, variations, or omissions are contemplated):

1) Place valve in warm saline bath (approx. 37° C.) for 10 seconds toexpand the valve;2) Place delivery system's delivery cone in the conical reducer andclose the door; and confirm the latch is engaged;3) Chill valve in approx. 5° C. sterile saline ice bath (30 seconds);4) Collect gathering suture with snare and pull gather suture throughthe rear of the delivery system handle;5) Place valve in the conical reducer, aligning valve tabs with thereducer slots;6) Place valve driver in the conical reducer, aligning the three driverprongs with the reducer slots;7) Collect excess gathering suture (In embodiments it may be importantto NOT pull the valve into the conical reducer with the gather suture);8) Advance valve until valve driver has advanced fully;9) Collect excess gathering suture and press lock button on deliverysystem handle;10) Remove valve driver from conical reducer;11) Open the conical reducer's door and remove the delivery system withvalve in the delivery system cone;12) Manually seat the valve in the delivery system cone; and13) Press the unlock button on the delivery system handle and collectexcess gathering suture, and press the lock button on the deliverysystem handle when complete.

Other crimping apparatus are contemplated herein. For example, the iriscrimper illustrated in FIG. A60 of U.S. Provisional Patent ApplicationNo. 61/819,488.

Sizers

Various aortic valve sizer instruments that facilitate accurate valvesize determination for sutureless aortic valve implantation proceduresare disclosed herein.

Shown below in FIGS. 47A-J are sizer concepts that features multiplediameters on a single sizer head. One configuration 1010 has a constanttaper with a marker at each 1 mm diameter increment, while another 1020has vertical walls with a step at each diameter transition. The laterconfiguration provides tactile feel between each size. Markers areplaced within the sizer at the level of the transition, allowing one toknow the diameter based on the depth of the sizer. The markings face theuser. This configuration has just three sizes, but less or more sizescould be placed on each sizer head.

Shown in FIGS. 48A-C are various sizer heads that encompass geometrythat replicates or approximates key features of the prosthesis to aid asurgeon in selecting the appropriate sized prosthesis. In the depictedembodiments, a flange is present which mimics the geometry of theprosthesis inflow cuff. The top portion of the cuff is mimicked as theinsertion of the sizer into the aortic valve annulus generally would notbe possible if the bottom flange were also present. The actual geometryof replica cuff would attempt to mimic the geometry of the prosthesiscuff as it would be in the actual anatomy, which may be angled inslightly due to the elastic properties of nitinol. Additionally, someinterference may be designed into the cuff geometry or lower barrel onthe sizer to simulate the radial force that the valve would have on theannulus.

The outflow portion of the replica sizer head mimics or approximates theheight and geometric features of the prosthesis. Gaps could be placedbetween the leaflet commissures on the sizer head to illustrate the areathat is accessible via catheter for coronary stent procedures (the onlyarea inaccessible to a catheter for coronary stent procedure may be atthe valve commissures). Alternatively, lines could be printed on theoutflow portion of the sizer indicating the stent and leaflet geometry(not shown). Bullet tips are shown below, though a standard cylinder atthe inflow end of the sizer is also considered.

Go/No-Go Sizer Head

A go/no-go sizer 1040, FIG. 49, has been contemplated that allows asurgeon to select a prosthesis size by process of elimination. The sizerhas a distal end portion of a diameter smaller than the sizer and aproximal end portion the size of the sizer. By way of example and for asize 23 mm sizer, the distal end of the sizer may have a diameter of 22mm and the proximal end may have a diameter of 23 mm. Likewise, for a 25mm sizer, the distal end of the sizer may have a diameter of 24 mm andthe proximal end may have a diameter of 26 mm.

When using the sizer, the surgeon would insert sequentially largersizers until the proximal end of the sizer does not comfortably passthrough the aortic valve annulus. The appropriate prosthesis would thenbe equal to the smallest sizer with the proximal end that would notpass.

Another version of this go/no-go sizer 1050, FIG. 50, could have acontinuous taper rather than a step between the two diameters on thesizer head.

To facilitate easier insertion of the sizer head into the annulus abullet tipped sizer head is contemplated herein, where the geometry isdesigned to mimic hegar sizers. The difference between a hegar sizer andthis aortic valve sizer is that this sizer will have transparent wallsand will be shorter in overall length.

A self-expanding sizer has also been contemplated herein in. To give theuser a feel for what the self-expanding prosthesis would actually feellike, an elastic replica component is contemplated that would deployinto the annulus and provide identical force representation of theactual valve prosthesis. This component could simply be a duplicate ofthe valve frame or could be of a less expensive alternative materialsuch as plastic or spring steel.

Double ended sizer handle 1060, FIG. 51, and single ended sizer handle1070, FIG. 52, are also contemplated herein. For a single ended sizerhandle, by having the size etched on the end facing the user, the usermay much more easily see the size of the sizer during sizing (FIGS.51-52). Similarly, a ramp like feature could be added to the doubleended sizer to achieve the same affect (not shown).

Additional Delivery Systems

Some additional embodiments of delivery systems that may be used todeliver prosthetic valves are provided below.

In some embodiments a delivery tool includes a rotary shaft. Thedelivery tool preferably allows a prosthetic valve to be delivered,deployed, recaptured, and repeated as necessary. In various embodimentsthe delivery tools have a rotatable shaft that controls constriction andexpansion of a self-expanding prosthetic valve. Turning in one directionconstricts the prosthetic valve, while turning in the other directionallows for controlled expansion of the prosthetic valve.

Referring now to FIG. 53, an embodiment of a delivery tool having arotary shaft is depicted. The tool has a handle 1100 and stationaryshaft 1120. The handle includes a rotatable ring actuator 1110 that iscoupled to a rotary shaft 130 disposed within at least a portion ofstationary shaft 1100. The ring 1100 can be turned clockwise orcounterclockwise to cause rotary shaft 1130 to rotate clockwise orcounterclockwise. Posts 1150 may be connected to stationary shaft 1120.Posts 1150 are positioned and configured to retain a prosthetic valveand prevent the valve from rotating when the tool is used to constrictor expand the valve. The tool further includes coil arms 1140 configuredto be attached to the prosthetic valve. The coil arms 1140 are coupledto the rotary shaft 1130.

The tool depicted in FIG. 53 can be used as follows. A prosthetic valve(not shown in FIG. 53) may be slid over the distal end of the tool. Thecoil arms 1140 can then be hooked onto the valve. The valve may be heldin place as the actuator ring 1100 is twisted to allow the prostheticvalve drop into posts 1150, which constrain the valve from rotationalmovement and lets the arms 1140 pull the valve inward as they twist andpull tight. The actuator ring 1110 can continued to be turned, causingthe rotary shaft 1130 to twists coil arms 1140. Arms 1140 are hooked onthe valve, and the valve is not able to move due to post 1150. Twistingwill cause arms 1140 to pull tight, compressing the valve to a loadedposition.

The delivery system can then be placed into the patient. A safety unlockmay be pressed while turning the actuator ring 1110 to release thevalve. The position of the valve may be checked. If the position isunacceptable, the valve may be recaptured recapture by twisting actuatorring 1110 to tighten the coils 1140. If the position of the valve isacceptable, the coils 1140 can then be freed from the valve bydisengaging the hook manually.

FIGS. 54A-C show a sequence of rotating to tighten (FIG. 54A to FIG.54B) and loosen (FIG. 54B to FIG. 54C) coil arms (valve not shown).

In some embodiments, a delivery tool includes a jubilee clip type thatcan be expanded and collapsed by rotating a handle. Referring now toFIG. 55 an embodiment of such a tool is shown. The tool includes ahandle 1200, stationary shaft 1210, rotary shaft 1220, cone 1230 andband 1240. When the handle 1200 is turned, rotatable shaft 1220 turnscausing cone 1230 to expand or constrict band 1240. A valve may beplaced within band 1240.

Referring now to FIG. 56, another embodiment of a jubilee clip typedevice is shown. The device includes a handle 1200, shaft 1210, screwmechanism 1250, and band 1240. Turning handle 1200 causes shaft 1210 toturn, thereby actuating screw mechanism 1250 to constrict or expand band1240.

In some embodiments, a shaft of s delivery tool lengthens or shortens toincrease or decrease tension on a frame of a prosthetic valve toconstrict or expand the prosthetic valve. Referring now to FIGS. 57-59,an embodiment of such a tool is shown. The tool includes tethers 1300attached to frame 24 of device at inflow and outflow ends. The tethers1300 are connected to internally threaded elements 1310, 1312. Element1310 is threaded in the opposite direction as element 1312. A shaft 1320has first threads 1322 and second threads 1324 spaced apart from thefirst threads 1322. The threads 1322, 1324 are configured to engageinternally threaded elements 1310, 1312 such that rotation of shaftcaused the distance between elements 1310, 1312 to increase or decreasedepending on the direction that the shaft is rotated. As depicted inFIG. 59, internally threaded elements 1310, 1320 may include fixationbars 1399 to ensure movement of the threaded elements and prevent themfrom rotating with the shaft. The fixation bars 1399 can extend andcollapse with the movement of the threaded features. FIG. 60 shows andembodiment with two movements with two shafts.

In some embodiments, a delivery tool includes a rotatable element towhich sutures are connected. The sutures maybe connected to a frame aprosthetic valve. When the element is rotated, the sutures tighten orloosen around the frame to control constriction and expansion of theprosthetic valve. An example such a system is depicted in FIGS. 61-64.The device includes a collar 1400 on which the prosthesis may sit. Thecollar may be clear or could be removable. One or more sutures 1410 maybe placed around at least a portion of frame 24 of device. Sutures 1410may pass through slots 1402 in collar 1400 and down through handle 1430and connected to rotatable actuator element 1440. Rotatable actuatorelement 1440 and at least a portion of handle 1430 are complementarilythreaded. Rotation of element 1440 in one direction causes the distancebetween element 1440 and prosthesis to increase and causes frame 24 toconstrict. Rotation of element 1440 in the opposite direction causes thedistance between element 1440 and prosthesis to decrease and allowsframe 24 to expand. FIG. 65 shows interconnected sutures that 1421,1422, 1423 that may be employed with a system depicted in FIGS. 61-64.

In some embodiments, a control arms delivery system is employed todeliver a self-expanding prosthetic device. Preferably, the systemallows for deployment, recapture and repeat, as necessary. In someembodiments, a user controls a sliding sheath to cause control arms tomover radially in or out, which causes the prosthesis to constrict orexpand. In some embodiments, the delivery system includes hooks, whichmay be triangular, that clasp into a frame of a prosthesis naturallywhen in tension and can be released by pushing forward when theprosthesis is expanded. In some embodiments, a delivery has two shaftsthat control the inflow and outflow of a prosthetic valve separately, sothat a user can deploy the inflow to check the seating. After visiblychecking the positioning, the user can recollapse and reposition ifneeded or actuate the second shaft to fully expand the valve and pushforward to disengage.

Referring now to FIGS. 66-68, an embodiment of a control arm deliverysystem is depicted. The system includes a handle 1530, a slide ring1540, control arms 1510 coupled to handle 1530, and shaft 1520 connectedto handle 1530. Control arms 1510 include hooks 1515 that may betriangular and interact with frame 24 of prosthesis. Control arms 1510are naturally flared outward and are shaped such that sliding of ring1540 upward cause arms 1510 to move inwardly, thereby constricting frame24.

Referring now to FIGS. 69-72, an embodiment of a control arm deliverysystem is depicted in which an inflow and outflow of a frame 24 of aprosthetic valve may be independently controllable. The delivery systemincludes an outer shaft 1620 advanceable over outer control arms 1625,which may be control arms as described above with regard to FIGS. 66-68.The delivery system further includes an inner shaft 1610 advanceableover inner control arms 1615, which may be control arms as describedabove with regard to FIGS. 66-68. Control arms 1625 may be connected toan inflow portion of frame 24. Control arms 1615 may be connected to anoutflow portion of frame 24. The inner shaft 1610 may be pushed downover control arms 1615 to cause the arms to move inwardly, causing theoutflow portion of frame 24 to constrict. The outer shaft 1620 may bepushed down over control arms 1625 to cause the arms to move inwardly,causing the inflow portion of frame 24 to constrict.

Referring now to FIG. 73 an embodiment of a control arm delivery systemis depicted. The delivery system includes a stationary handle 1710 androd 1720 attached to handle 1710, an inner outflow control arm actuator1730 (such as a sliding ring) and an outer inflow control arm actuator1740 (such as sliding ring) and outflow 1735 and inflow 1745 controlarms. Outflow control arms 1735 include hooks 1738, and inflow controlarms 1745 include hooks 1748. Hooks 1738, 1748 are triangular and locknaturally into a frame of a prosthetic valve. Hooks 1738, 1748 staylocked when the frame is collapsed, but when the frame is expanded andthe delivery system is pushed forward the hooks will naturally pop out.When the inflow actuator 1740 is fully retracted (closer to handle1710), the inflow portion of frame is expanded. When the inflow actuator1740 is fully advances (further from handle 1710), the inflow portion offrame is constricted. When the outflow actuator 1730 is fully retracted(closer to handle 1710), the outflow portion of frame is expanded. Whenthe outflow actuator 1730 is fully advances (further from handle 1710),the outflow portion of frame is constricted. The inflow and outflowportions of a frame of a prosthetic valve may be independentlycontrolled.

Referring now to FIGS. 74A-B, drawings of an embodiment of a prototypecontrol arm delivery system is shown. The delivery system includes ahandle 1810, control arms 1820 and actuation ring 1830. As ring 1830 isadvanced over arms 1830, arms 1840 move inwardly (compare FIG. 74A toFIG. 74B).

DEFINITIONS

All scientific and technical terms used herein have meanings commonlyused in the art unless otherwise specified. The definitions providedherein are to facilitate understanding of certain terms used frequentlyherein and are not meant to limit the scope of the present disclosure.

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” encompass embodiments having pluralreferents, unless the content clearly dictates otherwise.

As used in this specification and the appended claims, the term “or” isgenerally employed in its sense including “and/or” unless the contentclearly dictates otherwise.

As used herein, “have”, “having”, “include”, “including”, “comprise”,“comprising” or the like are used in their open ended sense, andgenerally mean “including, but not limited to”. It will be understoodthat “consisting essentially of”, “consisting of”, and the like aresubsumed in “comprising” and the like.

Summary of Some Select Embodiments

A number of embodiments of devices, systems, and methods are describedherein. A summary of some aspects of some embodiments described aboveare presented below.

In a first aspect, a system includes a medical device for implanting ina valve of a subject. The implantable medical device has aself-expanding frame (such as a prosthetic heart valve frame), and aholder configured to retain the frame of the implantable medical devicein a constricted configuration and to control expansion of the frame.The holder comprises a first controllably constrictable and expandableloop, wherein the first loop is disposed about at least a portion of theself-expanding frame such that constriction or expansion of the firstloop controls constriction or expansion of the frame.

A second aspect is a system according to the first aspect wherein theframe comprises an inflow region, wherein the inflow region comprises anupper portion and a lower portion, and wherein the first loop isdisposed about at least a portion of the upper portion of the inflowregion of the frame such that constriction or expansion of the firstloop controls constriction or expansion of the upper portion of theinflow region of the frame.

A third aspect is a system according to the second aspect wherein theholder comprises a second controllably constrictable and expandableloop, wherein the second loop is disposed about at least a portion ofthe lower portion of the inflow region of the frame such thatconstriction or expansion of the second loop controls constriction orexpansion of the lower portion of the inflow region of the frame.

A fourth aspect is a system according the third aspect wherein the firstand second loop are independently controllably constrictable andexpandable.

A fifth aspect is a system according the third aspect, wherein the framecomprises an outflow region and wherein the holder comprises a thirdcontrollably constrictable and expandable loop, wherein the third loopis disposed about at least a portion of the outflow region of the framesuch that constriction or expansion of the third loop controlsconstriction or expansion of at least a portion of the outflow region ofthe frame.

A sixth aspect is a system according to the fifth aspect, wherein thefirst loop is independently controllably constrictable and expandablerelative to the second and third loops.

A seventh aspect is a system according to the sixth aspect, wherein thesecond and third loops are together controllably constrictable andexpandable.

An eighth aspect is a system according to the sixth aspect wherein thefirst loop is a portion of a first cord, wherein the second loop is aportion of a second cord, wherein the third loop is a portion of a thirdcord, wherein the holder comprises a first extension member having afirst opening, a second opening and a conduit between the first andsecond openings, wherein the holder comprises a second extension memberhaving a first opening, a second opening and a conduit between the firstand second openings, wherein a portion of the first cord extends throughthe conduit of the first extension member, and wherein a portion of thesecond and third cords extend through the conduit of the secondextension member.

A ninth aspect is a system according to the eighth aspect, wherein theframe has a longitudinal axis and wherein the holder is configured suchthat the first and second extension members are offset from thelongitudinal axis of the frame and are substantially parallel to thelongitudinal axis of the frame when the holder constricts the frame orretains the frame in a constricted configuration.

A tenth aspect is a system according to the ninth aspect, wherein thefirst and second extension members are positioned external to the framewhen the holder constricts the frame or retains the frame in aconstricted configuration.

An eleventh aspect is a system according to the eighth aspect, whereinthe first cord comprises a suture forming the first loop and a tetherattached to an end of the suture, wherein the second cord comprises asuture forming the second loop and a tether attached to an end of thesuture, and wherein the third cord comprises a suture forming the thirdloop and a tether attached to an end of the suture.

A twelfth aspect is a system according to the eighth aspect, wherein theholder comprises an adapter configured to cooperatively mate with ashaft, where the adaptor comprises first and second lumens extendingthrough the adaptor, and wherein a portion of the first cord extendsthrough the first lumen such that an end of the first cord extendsbeyond the adaptor and wherein a portion of the second cord extendsthrough the second lumen such that an end of the second cord extendsbeyond the adaptor.

A thirteenth aspect is a system according to the twelfth aspect, furthercomprising the shaft, wherein the shaft defines one or more lumensthrough the shaft, wherein the shaft is configured to couple to theadaptor of the holder, and wherein a portion of the first cord extendsthrough one of the one or more lumens of the shaft such that an end ofthe first cord extends beyond the shaft and wherein a portion of thesecond cord extends through one of the one or more lumens of the shaftsuch that an end of the second cord extends beyond the adaptor, whereinthe portions of the first and second cords extend through the same lumenor different lumens of the shaft.

A fourteenth aspect is a system according to the thirteenth aspect,further comprising a handle operably coupled to, or operably couplableto, the shaft.

A fifteenth aspect is a system according to the fourteenth aspect,wherein the handle comprises a first actuation element operablycouplable to the end of the first cord such that constriction andexpansion of the first loop is controllable via the first actuationelement.

A sixteenth aspect is a system according to the fifteenth aspect,wherein the handle comprises a second actuation element operablycouplable to the end of the second cord such that constriction andexpansion of the second loop is controllable via the second actuationelement.

A seventeenth aspect is a system according to the sixteenth aspect,wherein the second actuation element is operably couplable to the end ofthe third cord such that constriction and expansion of the third loop iscontrollable via the second actuation element.

An eighteenth aspect is a system according to the fifteenth aspect,further comprises a control unit tethered to the handle, wherein thecontrol until comprises an actuation element operably couplable to theend of the second cord such that constriction and expansion of thesecond loop is controllable via the control unit actuation element Anineteenth aspect is a system according to the fourteenth aspect,further comprising a control unit operably coupled to the handle,wherein the control unit comprises a first actuation element operablycouplable to the end of the first cord such that constriction andexpansion of the first loop is controllable via the first actuationelement.

A twentieth aspect is a system according to the nineteenth aspect,wherein the control unit comprises a second actuation element operablycouplable to the end of the second cord such that constriction andexpansion of the second loop is controllable via the second actuationelement.

A twenty-first aspect is a system according to the twentieth aspect,wherein the second actuation element is operably couplable to the end ofthe third cord such that constriction and expansion of the third loop iscontrollable via the second actuation element.

A twenty-second aspect is a system according to the first aspect,wherein the holder further comprises a second controllably constrictableand expandable loop, wherein the second loop is disposed about at leasta portion of the self-expanding frame such that constriction orexpansion of the first loop controls constriction or expansion of theframe.

A twenty-third aspect is a system according to the twenty-second,wherein the holder further comprises a third controllably constrictableand expandable loop, wherein the third loop is disposed about at least aportion of the self-expanding frame such that constriction or expansionof the first loop controls constriction or expansion of the frame.

A twenty-fourth aspect is a system according to the twenty-third aspect,wherein the first, second, and third loops together are disposed about acircumference of the frame.

A twenty-fifth aspect is a system according to the twenty-third aspect,wherein constriction and expansion of the first, second and third loopsare independently controllable.

A twenty-sixth aspect is a system according to the twenty-third aspect,wherein constriction and expansion of the first loop is independentlycontrollable relative to the second and third loops, whereinconstriction and expansion of the second and third loops are controlledtogether.

A 27^(th) aspect is a system according to the 22^(nd) aspect, whereinthe first loop is a portion of a first cord, wherein the second loop isa portion of a second cord, and wherein the holder comprises a firstextension member having a first opening, a second opening and a conduitbetween the first and second openings, wherein the holder comprises asecond extension member having a first opening, a second opening and aconduit between the first and second openings, wherein a portion of thefirst cord extends through the conduit of the first extension member,and wherein a portion of the second cord extend through the conduit ofsecond extension member.

A 28^(th) aspect is a system according to the 27^(th) aspect, whereinthe frame has a longitudinal axis and wherein the holder is configuredsuch that the first and second extension members are offset from thelongitudinal axis of the frame and are substantially parallel to thelongitudinal axis of the frame when the holder constricts the frame orretains the frame in a constricted configuration.

A 29^(th) aspect is a system according to the 28^(th) aspect, whereinthe first and second extension members are positioned external to theframe when the holder constricts the frame or retains the frame in aconstricted configuration.

A 30^(th) aspect is a system according to the 23^(rd) aspect, whereinthe first loop is a portion of a first cord, wherein the second loop isa portion of a second cord, wherein the third loop is a portion of athird cord, wherein the holder comprises a first extension member havinga first opening, a second opening, and a conduit between the first andsecond openings, wherein the holder comprises a second extension memberhaving a first opening, a second opening, and a conduit between thefirst and second openings, wherein the holder comprises a thirdextension member having a first opening, a second opening, and a conduitbetween the first opening and the second opening, and wherein a portionof the first cord extends through the conduit of the first extensionmember, a portion of the second cord extends through the conduit of thesecond extension member, and a portion of the third cord extend throughthe conduit of third extension member.

A 31^(st) aspect is a system according to the 30^(th) aspect, whereinthe frame has a longitudinal axis and wherein the holder is configuredsuch that the first, second, and third members extend into a centralopening of the frame at an angle relative to the longitudinal axis ofthe frame when the frame is expanded.

A 32^(nd) aspect is a system according to the 1^(st) aspect, wherein theframe has a longitudinal axis, wherein the holder further comprises anextension member having a first opening, a second opening, and a conduitbetween the first and second openings, wherein the first loop is part ofa first cord and wherein a portion of the first cord extends through theconduit of the extension member, and wherein the holder is configuredsuch that the extension member is offset from the longitudinal axis ofthe frame and is substantially parallel to the longitudinal axis of theframe when the holder constricts the frame or retains the frame in aconstricted configuration.

A 33^(rd) aspect is a system according to the 32^(nd) aspect, whereinthe holder is configured such that the extension member is positionedexternal to the frame when the holder constricts the frame or retainsthe frame in a constricted configuration.

A 34^(th) aspect is a delivery system for implanting a medical devicehaving a self-expanding frame in a valve sinus of a subject. Thedelivery system includes a holder configured to retain the frame of theimplantable medical device in a constricted configuration and to controlexpansion of the frame. The holder comprises a first controllablyconstrictable and expandable loop configured to be disposed about atleast a portion of the self-expanding frame such that constriction orexpansion of the first loop controls constriction or expansion of theframe.

A 35^(th) aspect is a system according to the 34^(th) aspect, whereinthe holder comprises a second controllably constrictable and expandableloop configured to be disposed about at least a portion of theself-expanding frame such that constriction or expansion of the secondloop controls constriction or expansion of the lower portion of theinflow region of the frame.

A 36^(th) aspect is a system according to the 35^(th) aspect, whereinthe first and second loop are independently controllably constrictableand expandable.

A 37^(th) aspect is a system according to the 35^(th) aspect, whereinthe first loop is a portion of a first cord, wherein the second loop isa portion of a second cord, wherein the holder comprises a firstextension member having a first opening, a second opening, and a conduitbetween the first and second openings, wherein the holder comprises asecond extension member having a first opening, a second opening, and aconduit between the first and second openings, wherein a portion of thefirst cord extends through the conduit of the first extension member andwherein a portion of the second and third cords extend through theconduit of the second extension member.

A 38^(th) aspect is a system according to the 37^(th) aspect, whereinthe first and second extension members are configured to be offset froma longitudinal axis of the frame and are configured to be substantiallyparallel to the longitudinal axis of the frame when the holderconstricts the frame or retains the frame in a constrictedconfiguration.

A 39^(th) aspect is a system according to the 38^(th) aspect, whereinthe first and second extension members are positioned external to theframe when the holder constricts the frame or retains the frame in aconstricted configuration.

A 40^(th) aspect is a system according to the 37^(th) aspect, whereinthe holder is configured such that first, second, and third members areconfigured to extend into a central opening of the frame at an anglerelative to a longitudinal axis of the frame when the frame is expanded.

A 41^(st) aspect is a system according to the 37^(th) aspect, whereinthe holder comprises an adapter configured to cooperatively mate with ashaft, where the adaptor comprises first and second lumens extendingthrough the adaptor, and wherein a portion of the first cord extendsthrough the first lumen such that an end of the first cord extendsbeyond the adaptor and wherein a portion of the second cord extendsthrough the second lumen such that an end of the second cord extendsbeyond the adaptor.

A 42^(nd) aspect is a system according to the 41^(st) aspect, furthercomprising the shaft, wherein the shaft defines one or more lumensthrough the shaft, wherein the shaft is configured to couple to theadaptor of the holder, and wherein a portion of the first cord extendsthrough one of the one or more lumens of the shaft such that an end ofthe first cord extends beyond the shaft and wherein a portion of thesecond cord extends through one of the one or more lumens of the shaftsuch that an end of the second cord extends beyond the adaptor, whereinthe portions of the first and second cords extend through the same lumenor different lumens of the shaft.

A 43^(rd) aspect is a system according to the 42^(nd) aspect, furthercomprising a handle operably coupled to, or operably couplable to, theshaft.

A 44^(th) aspect is a system according to the 43^(rd) aspect, whereinthe handle comprises a first actuation element operably couplable to theend of the first cord such that constriction and expansion of the firstloop is controllable via the first actuation element.

A 45^(th) aspect is a system according to the 44^(th) aspect, whereinthe handle comprises a second actuation element operably couplable tothe end of the second cord such that constriction and expansion of thesecond loop is controllable via the second actuation element.

A 46^(th) aspect is a system according to the 43^(rd) aspect, furthercomprising a control unit operably coupled to the handle, wherein thecontrol unit comprises a first actuation element operably couplable tothe end of the first cord such that constriction and expansion of thefirst loop is controllable via the first actuation element.

A 47^(th) aspect is a system according to the 34^(th) aspect, whereinthe holder further comprises an extension member having a first opening,a second opening, and a conduit between the first and second openings,wherein the first loop is part of a first cord and wherein a portion ofthe first cord extends through the conduit of the extension member, andwherein the holder is configured such that the extension member isoffset from a longitudinal axis of the frame and is substantiallyparallel to the longitudinal axis of the frame when the holderconstricts the frame or retains the frame in a constrictedconfiguration.

A 48^(th) aspect is a system according to the 47^(th) aspect, whereinthe holder is configured such that the extension member is positionedexternal to the frame when the holder constricts the frame or retainsthe frame in a constricted configuration.

A 49^(th) aspect is a method for implanting a medical device having aself-expanding frame in a valve of a patient. The method includesinserting the device into the valve annulus of the patient, wherein theframe is in a constricted configuration; and expanding a loop disposedaround at least a portion of the frame to allow the frame to expand tocause at least a portion of the device to engage at least a portion ofthe native valve annulus.

A 50^(th) aspect is a method according to the 49^(th) aspect, whereinthe device is a prosthetic heart valve and wherein the self-expandableframe comprises an inflow region of the prosthetic heart valve, whereinthe inflow region comprises an upper portion and a lower portion, andwherein the loop is disposed about at least a portion of the upperportion of the inflow region of the frame such that expansion of theloop allows the upper portion of the inflow region of the frame toexpand.

A 51^(st) aspect is a method according to the 49^(th) aspect, whereinthe loop is in the form of a cinch suture.

Thus, embodiments of VALVE DELIVERY TOOL are disclosed. One skilled inthe art will appreciate that the heart valves and associatedapparatuses, systems and methods described herein can be practiced withembodiments other than those disclosed. The disclosed embodiments arepresented for purposes of illustration and not limitation.

What is claimed is:
 1. A system comprising: a medical device forreplacing a valve of a subject, the implantable medical device having aself-expanding frame; and a holder configured to retain the frame of theimplantable medical device in a constricted configuration and to controlexpansion of the frame, wherein the holder comprises a firstcontrollably constrictable and expandable loop, wherein the first loopis disposed about at least a portion of the self-expanding frame suchthat constriction or expansion of the first loop controls constrictionor expansion of the frame.
 2. A system according to claim 1, wherein theframe comprises an inflow region, wherein the inflow region comprises anupper portion and a lower portion, and wherein the first loop isdisposed about at least a portion of the upper portion of the inflowregion of the frame such that constriction or expansion of the firstloop controls constriction or expansion of the upper portion of theinflow region of the frame.
 3. A system according to claim 2, whereinthe holder comprises a second controllably constrictable and expandableloop, wherein the second loop is disposed about at least a portion ofthe lower portion of the inflow region of the frame such thatconstriction or expansion of the second loop controls constriction orexpansion of the lower portion of the inflow region of the frame.
 4. Asystem according to claim 3, wherein the first and second loop areindependently controllably constrictable and expandable.
 5. A systemaccording to claim 3, wherein the frame comprises an outflow region andwherein the holder comprises a third controllably constrictable andexpandable loop, wherein the third loop is disposed about at least aportion of the outflow region of the frame such that constriction orexpansion of the third loop controls constriction or expansion of atleast a portion of the outflow region of the frame.
 6. A systemaccording to claim 5, wherein the first loop is independentlycontrollably constrictable and expandable relative to the second andthird loops.
 7. A system according to claim 6, wherein the second andthird loops are together controllably constrictable and expandable.
 8. Asystem according to claim 6, wherein the first loop is a portion of afirst cord, wherein the second loop is a portion of a second cord,wherein the third loop is a portion of a third cord, wherein the holdercomprises a first extension member having a first opening, a secondopening and a conduit between the first and second openings, wherein theholder comprises a second extension member having a first opening, asecond opening and a conduit between the first and second openings,wherein a portion of the first cord extends through the conduit of thefirst extension member, and wherein a portion of the second and thirdcords extend through the conduit of the second extension member.
 9. Asystem according to claim 8, wherein the frame has a longitudinal axisand wherein the holder is configured such that the first and secondextension members are offset from the longitudinal axis of the frame andare substantially parallel to the longitudinal axis of the frame whenthe holder constricts the frame or retains the frame in a constrictedconfiguration.
 10. A system according to claim 9, wherein the first andsecond extension members are positioned external to the frame when theholder constricts the frame or retains the frame in a constrictedconfiguration.
 11. A system according to claim 8, wherein the first cordcomprises a suture forming the first loop and a tether attached to anend of the suture, wherein the second cord comprises a suture formingthe second loop and a tether attached to an end of the suture, andwherein the third cord comprises a suture forming the third loop and atether attached to an end of the suture.
 12. A system according to claim8, wherein the holder comprises an adapter configured to cooperativelymate with a shaft, where the adaptor comprises first and second lumensextending through the adaptor, and wherein a portion of the first cordextends through the first lumen such that an end of the first cordextends beyond the adaptor and wherein a portion of the second cordextends through the second lumen such that an end of the second cordextends beyond the adaptor.
 13. A system according to claim 12, furthercomprising the shaft, wherein the shaft defines one or more lumensthrough the shaft, wherein the shaft is configured to couple to theadaptor of the holder, and wherein a portion of the first cord extendsthrough one of the one or more lumens of the shaft such that an end ofthe first cord extends beyond the shaft and wherein a portion of thesecond cord extends through one of the one or more lumens of the shaftsuch that an end of the second cord extends beyond the adaptor, whereinthe portions of the first and second cords extend through the same lumenor different lumens of the shaft.
 14. A system according to claim 13,further comprising a handle operably coupled to, or operably couplableto, the shaft.
 15. A system according to claim 14, wherein the handlecomprises a first actuation element operably couplable to the end of thefirst cord such that constriction and expansion of the first loop iscontrollable via the first actuation element.
 16. A system according toclaim 15, wherein the handle comprises a second actuation elementoperably couplable to the end of the second cord such that constrictionand expansion of the second loop is controllable via the secondactuation element.
 17. A system according to claim 16, wherein thesecond actuation element is operably couplable to the end of the thirdcord such that constriction and expansion of the third loop iscontrollable via the second actuation element.
 18. A system according toclaim 15, further comprises a control unit tethered to the handle,wherein the control until comprises an actuation element operablycouplable to the end of the second cord such that constriction andexpansion of the second loop is controllable via the control unitactuation element.
 19. A system according to claim 14, furthercomprising a control unit operably coupled to the handle, wherein thecontrol unit comprises a first actuation element operably couplable tothe end of the first cord such that constriction and expansion of thefirst loop is controllable via the first actuation element.
 20. A systemaccording to claim 19, wherein the control unit comprises a secondactuation element operably couplable to the end of the second cord suchthat constriction and expansion of the second loop is controllable viathe second actuation element.
 21. A system according to claim 20,wherein the second actuation element is operably couplable to the end ofthe third cord such that constriction and expansion of the third loop iscontrollable via the second actuation element.
 22. A system according toclaim 1, wherein the holder further comprises a second controllablyconstrictable and expandable loop, wherein the second loop is disposedabout at least a portion of the self-expanding frame such thatconstriction or expansion of the first loop controls constriction orexpansion of the frame.
 23. A system according to claim 22, wherein theholder further comprises a third controllably constrictable andexpandable loop, wherein the third loop is disposed about at least aportion of the self-expanding frame such that constriction or expansionof the first loop controls constriction or expansion of the frame.
 24. Asystem according to claim 23, wherein the first, second, and third loopstogether are disposed about a circumference of the frame.
 25. A systemaccording to claim 23, wherein constriction and expansion of the first,second and third loops are independently controllable.
 26. A systemaccording to claim 23, wherein constriction and expansion of the firstloop is independently controllable relative to the second and thirdloops, wherein constriction and expansion of the second and third loopsare controlled together.
 27. A system according to claim 22, wherein thefirst loop is a portion of a first cord, wherein the second loop is aportion of a second cord, and wherein the holder comprises a firstextension member having a first opening, a second opening and a conduitbetween the first and second openings wherein the holder comprises asecond extension member having a first opening, a second opening and aconduit between the first and second openings, wherein a portion of thefirst cord extends through the conduit of the first extension member,and wherein a portion of the second cord extend through the conduit ofsecond extension member.
 28. A system according to claim 27, wherein theframe has a longitudinal axis and wherein the holder is configured suchthat the first and second extension members are offset from thelongitudinal axis of the frame and are substantially parallel to thelongitudinal axis of the frame when the holder constricts the frame orretains the frame in a constricted configuration.
 29. A system accordingto claim 28, wherein the first and second extension members arepositioned external to the frame when the holder constricts the frame orretains the frame in a constricted configuration.
 30. A system accordingto claim 23, wherein the first loop is a portion of a first cord,wherein the second loop is a portion of a second cord, wherein the thirdloop is a portion of a third cord, wherein the holder comprises a firstextension member having a first opening, a second opening, and a conduitbetween the first and second openings, wherein the holder comprises asecond extension member having a first opening, a second opening, and aconduit between the first and second openings, wherein the holdercomprises a third extension member having a first opening, a secondopening, and a conduit between the first opening and the second opening,and wherein a portion of the first cord extends through the conduit ofthe first extension member, a portion of the second cord extends throughthe conduit of the second extension member, and a portion of the thirdcord extend through the conduit of third extension member.
 31. A systemaccording to claim 30, wherein the frame has a longitudinal axis andwherein the holder is configured such that the first, second, and thirdmembers extend into a central opening of the frame at an angle relativeto the longitudinal axis of the frame when the frame is expanded.
 32. Asystem according to claim 1, wherein the frame has a longitudinal axis,wherein the holder further comprises an extension member having a firstopening, a second opening, and a conduit between the first and secondopenings, wherein the first loop is part of a first cord and wherein aportion of the first cord extends through the conduit of the extensionmember, and wherein the holder is configured such that the extensionmember is offset from the longitudinal axis of the frame and issubstantially parallel to the longitudinal axis of the frame when theholder constricts the frame or retains the frame in a constrictedconfiguration.
 33. A system according to claim 32, wherein the holder isconfigured such that the extension member is positioned external to theframe when the holder constricts the frame or retains the frame in aconstricted configuration.
 34. A delivery system for implanting amedical device having a self-expanding frame in a valve of a subject,the delivery system comprising: a holder configured to retain the frameof the implantable medical device in a constricted configuration and tocontrol expansion of the frame, the holder comprising a firstcontrollably constrictable and expandable loop configured to be disposedabout at least a portion of the self-expanding frame such thatconstriction or expansion of the first loop controls constriction orexpansion of the frame.
 35. A system according to claim 34, wherein theholder comprises a second controllably constrictable and expandable loopconfigured to be disposed about at least a portion of the self-expandingframe such that constriction or expansion of the second loop controlsconstriction or expansion of the lower portion of the inflow region ofthe frame.
 36. A system according to claim 35, wherein the first andsecond loop are independently controllably constrictable and expandable.37. A system according to claim 35, wherein the first loop is a portionof a first cord, wherein the second loop is a portion of a second cord,wherein the holder comprises a first extension member having a firstopening, a second opening, and a conduit between the first and secondopenings, wherein the holder comprises a second extension member havinga first opening, a second opening, and a conduit between the first andsecond openings, wherein a portion of the first cord extends through theconduit of the first extension member and wherein a portion of thesecond and third cords extend through the conduit of the secondextension member.
 38. A system according to claim 37, wherein the firstand second extension members are configured to be offset from alongitudinal axis of the frame and are configured to be substantiallyparallel to the longitudinal axis of the frame when the holderconstricts the frame or retains the frame in a constrictedconfiguration.
 39. A system according to claim 38, wherein the first andsecond extension members are positioned external to the frame when theholder constricts the frame or retains the frame in a constrictedconfiguration.
 40. A system according to claim 37, wherein the holder isconfigured such that first, second, and third members are configured toextend into a central opening of the frame at an angle relative to alongitudinal axis of the frame when the frame is expanded.
 41. A systemaccording to claim 37, wherein the holder comprises an adapterconfigured to cooperatively mate with a shaft, where the adaptorcomprises first and second lumens extending through the adaptor, andwherein a portion of the first cord extends through the first lumen suchthat an end of the first cord extends beyond the adaptor and wherein aportion of the second cord extends through the second lumen such that anend of the second cord extends beyond the adaptor.
 42. A systemaccording to claim 41, further comprising the shaft, wherein the shaftdefines one or more lumens through the shaft, wherein the shaft isconfigured to couple to the adaptor of the holder, and wherein a portionof the first cord extends through one of the one or more lumens of theshaft such that an end of the first cord extends beyond the shaft andwherein a portion of the second cord extends through one of the one ormore lumens of the shaft such that an end of the second cord extendsbeyond the adaptor, wherein the portions of the first and second cordsextend through the same lumen or different lumens of the shaft.
 43. Asystem according to claim 42, further comprising a handle operablycoupled to, or operably couplable to, the shaft.
 44. A system accordingto claim 43, wherein the handle comprises a first actuation elementoperably couplable to the end of the first cord such that constrictionand expansion of the first loop is controllable via the first actuationelement.
 45. A system according to claim 44, wherein the handlecomprises a second actuation element operably couplable to the end ofthe second cord such that constriction and expansion of the second loopis controllable via the second actuation element.
 46. A system accordingto claim 43, further comprising a control unit operably coupled to thehandle, wherein the control unit comprises a first actuation elementoperably couplable to the end of the first cord such that constrictionand expansion of the first loop is controllable via the first actuationelement.
 47. A system according to claim 34, wherein the holder furthercomprises an extension member having a first opening, a second opening,and a conduit between the first and second openings, wherein the firstloop is part of a first cord and wherein a portion of the first cordextends through the conduit of the extension member, and wherein theholder is configured such that the extension member is offset from alongitudinal axis of the frame and is substantially parallel to thelongitudinal axis of the frame when the holder constricts the frame orretains the frame in a constricted configuration.
 48. A system accordingto claim 47, wherein the holder is configured such that the extensionmember is positioned external to the frame when the holder constrictsthe frame or retains the frame in a constricted configuration.
 49. Amethod for implanting a medical device having a self-expanding frame ina valve of a patient, comprising: inserting the device into the valve ofthe patient, wherein the frame is in a constricted configuration; andexpanding a loop disposed around at least a portion of the frame toallow the frame to expand to cause at least a portion of the device toengage at least a portion of the valve.
 50. A method according to claim49, wherein the device is a prosthetic heart valve and wherein theself-expandable frame comprises an inflow region of the prosthetic heartvalve, wherein the inflow region comprises an upper portion and a lowerportion, and wherein the loop is disposed about at least a portion ofthe upper portion of the inflow region of the frame such that expansionof the loop allows the upper portion of the inflow region of the frameto expand.
 51. A method according to claim 49, wherein the loop is inthe form of a cinch suture.